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| ID | Type | Description | Link |
|---|---|---|---|
| GENENTECH PHARM | Other Identifier | Genentech Pharmaceuticals | |
| NCI-2009-00846 | Registry Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study adopts a novel strategy for first-line treatment of osteosarcoma by combining chemotherapy with anti-angiogenic therapy using bevacizumab (Avastin®), a humanized monoclonal antibody against vascular endothelial growth factor (VEGF). Chemotherapy for localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose methotrexate). Chemotherapy for metastatic or unresectable disease comprises a cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and etoposide.
This is a comprehensive study that uses a novel agent that targets angiogenesis (bevacizumab) in combination with conventional chemotherapy for the treatment of osteosarcoma. Bevacizumab, a monoclonal antibody against the vascular endothelial growth factor (VEGF), has been shown to stop the growth of new blood vessels of tumors, both in the laboratory and in patients with other types of cancers. Bevacizumab has improved the effect of chemotherapy in adult patients with different types of cancer by increasing tumor response and increasing the chances of survival. This study has two main goals:
The chemotherapy drugs used in this study are commonly used to treat osteosarcoma. Patients with non-metastatic and resectable tumors receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate. Patients with metastatic tumors or tumors that cannot be removed by surgery receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate, ifosfamide and etoposide. If the tumor can be removed by surgery, surgery will be performed after 10 weeks of chemotherapy and will be followed by additional chemotherapy. After completion of active therapy, patient's response to therapy will be followed for approximately 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Localized Resectable Disease (Stratum A) | Experimental | Participants with localized resectable disease receive Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin, and doxorubicin, or methotrexate. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, or methotrexate. |
|
| Metastatic Disease (Stratum B) | Experimental | Participants with metastatic disease (Stratum B) receive Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin and doxorubicin, methotrexate or ifosfamide, and etoposide. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, methotrexate, or ifosfamide, and etoposide. Radiotherapy will be given post-operatively. |
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| Unresectable Disease (Stratum C) | Experimental | Participants with unresectable disease (Stratum C) receive treatment identical to Stratum B: Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin and doxorubicin, methotrexate or ifosfamide, and etoposide. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, methotrexate, or ifosfamide, and etoposide. Radiotherapy will be given post-operatively. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Biological | Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unacceptable Toxicity | Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma. The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications. A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity. | After all patients have completed therapy, up to 1 year after last patient is enrolled |
| 3-Year Event Free Survival | To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) on the event-free survival (EFS) in patients with localized resectable osteosarcoma. The Kaplan-Meier (K-M) method was used to estimate survival rate. | After all patients have completed therapy, up to 4 years after last patient is enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic Response by Stratum | The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133. Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor). The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Neuropathic Pain (NP) Following Surgery | Of the 43 participants enrolled on this trial, 37 met criteria for evaluation of neuropathic pain (NP) following definitive surgery. The 37 participants underwent 38 surgeries: one participant had a limb-sparing surgery followed by an amputation surgery. Six of 43 participants were excluded from evaluation for NP: 1 due to deep vein thrombosis, 2 removed from study prior to surgery, 1 removed immediately after surgery to receive radiation therapy, 1 had non-extremity osteosarcoma, and 1 patient had a fibula resection. Patients were followed for neuropathic pain daily for the first week postoperatively and weekly for up to 6 months postoperatively. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bishop, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital and Health Center | San Diego | California | 92123 | United States | ||
| Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24637635 | Derived | Turner DC, Navid F, Daw NC, Mao S, Wu J, Santana VM, Neel M, Rao B, Willert JR, Loeb DM, Harstead KE, Throm SL, Freeman BB 3rd, Stewart CF. Population pharmacokinetics of bevacizumab in children with osteosarcoma: implications for dosing. Clin Cancer Res. 2014 May 15;20(10):2783-92. doi: 10.1158/1078-0432.CCR-13-2364. Epub 2014 Mar 17. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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All participants had newly diagnosed high-grade, biopsy-proven osteosarcoma, or malignant fibrous histiocytoma (MFH) of bone
Forty-three participants were enrolled between June 2008 and May 2012: 34 at St. Jude Children's Research Hospital, 6 at Rady Children's Hospital San Diego, 2 at Johns Hopkins University Hospital, and 1 at M.D. Anderson in Houston
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Localized Resectable Disease | Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis. |
| FG001 | B: Localized Unresectable Disease |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cisplatin | Drug | Given IV. |
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| Doxorubicin | Drug | Given IV. |
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| Methotrexate | Drug | Given IV. |
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| Ifosfamide | Drug | Given IV. |
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| etoposide | Drug | Given IV. |
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| Surgery | Procedure | Participants undergo definitive surgery and assessment of histologic response at week 10. |
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| Radiotherapy | Radiation | Radiation therapy delivered for positive margins or intralesional resections. |
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| After 6 cycles of chemotherapy, up to 1 year after the start of therapy |
| 2-Year Event Free Survival (EFS) of Patients With Osteosarcoma | Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab. | After all patients have completed therapy, up to 2 years after last patient is enrolled |
| 2-Year Overall Survival (OS) of Patients With Osteosarcoma | Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab. | After all patients have completed therapy, up to 2 years after last patient is enrolled |
| 2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol. | The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here. | After all patients have completed therapy, up to 2 years after last patient is enrolled |
| 2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol. | The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS2008 to that of OS99 (NCT00145639) participants was not done. The 2-year OS of OS2008 participants is reported here. | After all patients have completed therapy, up to 2 years after last patient is enrolled |
| Mean Ktrans | The volume transfer constant (Ktrans) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set. | Baseline through Week 10 |
| Mean Vp | The fractional blood plasma volume (Vp) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set. | Baseline through Week 10 |
| Mean Ve | The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set. | Baseline through Week 10 |
| Histologic Response by Number of Participants | The association of interested variables with response was checked with the Wilcoxon rank-sum test. The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. | at week 10 after start of therapy |
| Ktrans by Good and Poor Response | The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. | at week 10 after start of therapy |
| P95 of Ktrans by Good and Poor Response | The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. P95 denotes the level of each kinetic parameter exceeding 95% of its values in each tumor. | at week 10 after start of therapy |
| Difference Between Good and Poor Response by SUVmax | The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. | at week 10 after start of therapy |
| Up to 6 months postoperatively |
| Median Duration of Neuropathic Pain | Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group. | From surgery until resolution of NP symptoms, up to 6 months |
| Mean Duration of Neuropathic Pain | Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group. | From surgery until resolution of NP symptoms, up to 6 months |
| Median Duration of Neuropathic Pain Medication | Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group. | From surgery until resolution of NP symptoms, up to 6 months |
| Mean Duration of Neuropathic Pain Medication | Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group. | From surgery until resolution of NP symptoms, up to 6 months |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| NCI/NIH - Pediatric Oncology Branch | Bethesda | Maryland | 20892 | United States |
| St Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Clinical Trials Open at St. Jude | View source |
Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum. |
| FG002 | C: Metastatic Tumors | Stratum C participants had metastatic tumors. |
| COMPLETED |
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| NOT COMPLETED |
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Participants were eligible if they were ≤30 years of age on date of diagnostic biopsy confirmation of high-grade osteosarcoma or malignant fibrous histiocytoma (MFH) of bone. Participants had no previous chemotherapy or radiation therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Localized Resectable Disease | Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis. |
| BG001 | B: Localized Unresectable Disease | Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum. |
| BG002 | C: Metastatic Tumors | Stratum C participants had metastatic tumors. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Unacceptable Toxicity | Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma. The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications. A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity. | Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective. | Posted | Number | participants | After all patients have completed therapy, up to 1 year after last patient is enrolled |
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| Primary | 3-Year Event Free Survival | To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) on the event-free survival (EFS) in patients with localized resectable osteosarcoma. The Kaplan-Meier (K-M) method was used to estimate survival rate. | Posted | Number | 95% Confidence Interval | Probability | After all patients have completed therapy, up to 4 years after last patient is enrolled |
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| Secondary | Histologic Response by Stratum | The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133. Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor). The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done. | All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants. | Posted | Number | participants | After 6 cycles of chemotherapy, up to 1 year after the start of therapy |
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| Secondary | 2-Year Event Free Survival (EFS) of Patients With Osteosarcoma | Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab. | All the 42 evaluable participants were included in this analysis. | Posted | Number | 95% Confidence Interval | probability | After all patients have completed therapy, up to 2 years after last patient is enrolled |
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| Secondary | 2-Year Overall Survival (OS) of Patients With Osteosarcoma | Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab. | All the 42 evaluable participants in this study had osteosarcoma, of which 12 died and 20 were still alive as of 05/04/2015. | Posted | Number | 95% Confidence Interval | probability | After all patients have completed therapy, up to 2 years after last patient is enrolled |
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| Secondary | 2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol. | The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here. | OS2008 Localized Resectable Disease group had 31 participants: 14 had events, 17 had no events. | Posted | Number | 95% Confidence Interval | probability | After all patients have completed therapy, up to 2 years after last patient is enrolled |
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| Secondary | 2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol. | The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS2008 to that of OS99 (NCT00145639) participants was not done. The 2-year OS of OS2008 participants is reported here. | OS2008 Localized Resectable Disease group had 31 participants: 7 were expired and 24 still alive | Posted | Number | 95% Confidence Interval | probability | After all patients have completed therapy, up to 2 years after last patient is enrolled |
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| Secondary | Mean Ktrans | The volume transfer constant (Ktrans) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set. | The number analyzed at each time point differed due to missing observations at some of the time points | Posted | Mean | Standard Deviation | min(-1) | Baseline through Week 10 |
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| Secondary | Mean Vp | The fractional blood plasma volume (Vp) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set. | The number analyzed at each time point differed due to missing observations at some of the time points | Posted | Mean | Standard Deviation | (unitless) | Baseline through Week 10 |
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| Secondary | Mean Ve | The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set. | The number analyzed at each time point differed due to missing observations at some of the time points | Posted | Mean | Standard Deviation | (unitless) | Baseline through Week 10 |
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| Secondary | Histologic Response by Number of Participants | The association of interested variables with response was checked with the Wilcoxon rank-sum test. The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. | Two Stratum A participants with no histologic response were excluded. | Posted | Count of Participants | Participants | at week 10 after start of therapy |
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| Secondary | Ktrans by Good and Poor Response | The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. | Two Stratum A participants with no histologic response were excluded. | Posted | Mean | Standard Error | min(-1) | at week 10 after start of therapy |
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| Secondary | P95 of Ktrans by Good and Poor Response | The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. P95 denotes the level of each kinetic parameter exceeding 95% of its values in each tumor. | Two Stratum A participants with no histologic response were excluded. | Posted | Mean | Standard Error | min(-1) | at week 10 after start of therapy |
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| Secondary | Difference Between Good and Poor Response by SUVmax | The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. | One participant with no histologic response but with evaluable imaging was excluded. | Posted | Mean | Standard Error | (unitless) | at week 10 after start of therapy |
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| Other Pre-specified | Number of Participants With Neuropathic Pain (NP) Following Surgery | Of the 43 participants enrolled on this trial, 37 met criteria for evaluation of neuropathic pain (NP) following definitive surgery. The 37 participants underwent 38 surgeries: one participant had a limb-sparing surgery followed by an amputation surgery. Six of 43 participants were excluded from evaluation for NP: 1 due to deep vein thrombosis, 2 removed from study prior to surgery, 1 removed immediately after surgery to receive radiation therapy, 1 had non-extremity osteosarcoma, and 1 patient had a fibula resection. Patients were followed for neuropathic pain daily for the first week postoperatively and weekly for up to 6 months postoperatively. | Posted | Number | participants | Up to 6 months postoperatively | Number of Surgeries | Number of Surgeries |
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| Other Pre-specified | Median Duration of Neuropathic Pain | Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group. | All participants who met the criteria, had definitive surgery (either limb sparing or/and amputation), experienced neuropathic pain (NP) and were treated for NP until resolution of NP symptoms and off NP medications. | Posted | Median | Full Range | Weeks | From surgery until resolution of NP symptoms, up to 6 months | Number of Surgeries | Number of Surgeries |
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| Other Pre-specified | Mean Duration of Neuropathic Pain | Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group. | All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication. | Posted | Mean | Standard Deviation | Weeks | From surgery until resolution of NP symptoms, up to 6 months | Number of Surgeries | Number of Surgeries |
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| Other Pre-specified | Median Duration of Neuropathic Pain Medication | Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group. | All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication. | Posted | Median | Full Range | Weeks | From surgery until resolution of NP symptoms, up to 6 months | Number of Surgeries | Number of Surgeries |
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| Other Pre-specified | Mean Duration of Neuropathic Pain Medication | Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group. | Posted | Mean | Standard Deviation | Weeks | From surgery until resolution of NP symptoms, up to 6 months | Number of Surgeries | Number of Surgeries |
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Adverse events were recorded from on-study date through April 2015.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: Localized Resectable Disease | Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis. | 3 | 31 | 31 | 31 | ||
| EG001 | C: Metastatic Tumors | Stratum C participants had metastatic tumors. | 0 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia) | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
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| Cognitive disturbance | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Encephalopathy | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Neuropathy: motor | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Neuropathy: sensory | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam), oral cavity | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
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| Hemorrhage, pulmonary/upper respiratory, Nose | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L) |
|
| Pain, Abdomen NOS | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Weight loss | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, Head/headache | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, extremity-limb | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hearing: patients with/without baseline audiogram and enrolled in a monitoring program | Ear and labyrinth disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, oral cavity | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, throat/pharynx/larynx | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Supraventricular and nodal arrhythmia, sinus tachycardia | Cardiac disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, Back | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, chest/thorax NOS | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemoglobinuria | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, rectum | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| GGT (gamma-glutamyl transpeptidase) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic), oral cavity | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Prolonged QTc interval | Cardiac disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, skin (cellulitis) | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, esophagus | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GU, bladder | Renal and urinary disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, lower GI NOS | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, urethra | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, upper GI NOS | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GU, urinary NOS | Renal and urinary disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, joint | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, phantom (pain associated with missing limb) | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic), esophagus | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, catheter-related | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Glomerular filtration rate | Metabolism and nutrition disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, rectum | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Chelitis | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis) | Renal and urinary disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Conduction abnormality/atrioventricular heart block, conduction abnormality, NOS | Cardiac disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam), anus | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, anus | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, blood | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, stomach | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), skin (cellulitis) | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Documented clinically or microbiologically |
|
| Confusion | Psychiatric disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Irregular menses (change from baseline) | Reproductive system and breast disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, pain NOS | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, oral cavity | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, oral cavity-gums (gingivitis) | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, wound | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pulmonary/upper respiratory - other | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, pleura | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam), esophagus | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam), rectum | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), blood | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Documented clinically or microbiologically. |
|
| Joint-effusion | Musculoskeletal and connective tissue disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), oral cavity-gums | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Documented clinically or microbiologically. |
|
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, mucosa | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), catheter-related | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Documented clinically or microbiologically. |
|
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic), pharynx | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Bone age (alteration in bone age) | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), lung (pneumonia) | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Documented clinically or microbiologically. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils, bladder (urinary) | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, urinary tract NOS | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, anus | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Hemorrhage/bleeding - other | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Supraventricular and nodal arrhythmia, sinus arrhythmia | Cardiac disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), conjunctiva | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Documented clinically or microbiologically) |
|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), eye NOS | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), mucosa | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Documented clinically or microbiologically. |
|
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), urinary tract NOS | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Documented clinically or microbiologically. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils, lung (pneumonia) | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
| |
| Pain, lip | General disorders | CTCAE v3.0 | Non-systematic Assessment |
| |
| Infection (ANC <1.0 x 10e9/L, fever >38.5 degrees C.), blood | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment | Documented clinically or microbiologically. |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils, colon | Infections and infestations | CTCAE v3.0 | Non-systematic Assessment |
|
Accrual to this study was stopped early after 4.5 years due to slow accrual of participants. No eligible participants were enrolled on Stratum B. All enrolled participants continue on study and results will be reported when available.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Bishop, MD | St. Jude Children's Research Hospital | 866-278-5833 | referralinfo@stjude.org |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D051677 | Histiocytoma, Malignant Fibrous |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| D004317 | Doxorubicin |
| D008727 | Methotrexate |
| D007069 | Ifosfamide |
| D005047 | Etoposide |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Grade 4 Bleeding |
|
| Grade 3/4 Thrombosis/Embolism |
|
| Grade 2, 3 or 4 Major Wound Complication |
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