| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00031 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCI-5913 | |||
| UCCRC-NCI-5913 | |||
| CDR0000285683 | |||
| UCCRC-11965B | |||
| 11965B | Other Identifier | University of Chicago | |
| 5913 | Other Identifier | CTEP | |
| P30CA014599 | U.S. NIH Grant/Contract | View source | |
| N01CM62202 | U.S. NIH Grant/Contract | View source | |
| N01CM62201 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die.
OBJECTIVES:
I. Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with BMS-247550 (ixabepilone).
II. Determine the safety and toxicity of this drug in these patients. III. Determine the duration of response, overall survival, and time to progression in patients treated with this drug.
OUTLINE: This is a multi-center study.
Patients receive ixabepilone intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.
Patients are followed every 8 weeks until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemotherapy) | Experimental | Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ixabepilone | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Overall Response Rate | The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR. | up to 3 years |
| Safety and Toxicity of Ixabepilone | Number of patients experiencing adverse event grade 3 or above. Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Adverse events possibly, probably, or definitely attributed to use of ixabepilone. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Duration of response was measured from the time measurement criteria are met for CR(complete response)/CRu(unconfirmed complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the 1999 international response criteria as published by Cheson, CR/CRu is defined as the disappearance of all target lesions; PR is defined as >=50% decrease in the sum of the products of the greatest diameters; PD is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy. |
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Inclusion Criteria:
Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following cellular types:
Grade III follicular center
Diffuse large B-cell
Mantle cell
Primary mediastinal B-cell
Burkitt's
High-grade B-cell (Burkitt-like)
Anaplastic large cell of 1 of the following subtypes:
Relapsed or refractory disease after prior standard chemotherapy, meeting criteria for 1of the following cohorts:
Cohort 1 (relapsed but chemosensitive): Prior complete response (CR) or partial response (PR) lasting at least 4 weeks after the most recent prior therapy
Cohort 2 (refractory): Stable disease or less than a PR after the most recent prior therapy
Measurable disease
Ineligible for or unwilling to undergo hematopoietic stem cell transplantation
No known CNS involvement by lymphoma
Performance status - ECOG 0-2
More than 3 months
WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,200/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 mg/dL
AST/ALT no greater than 2.5 times upper limit of normal
Creatinine no greater than 1.5 mg/dL
Creatinine clearance at least 60 mL/min
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior allergic reaction or hypersensitivity to compounds containing Cremophor EL or agents of similar chemical or biological composition to BMS-247550
No peripheral neuropathy grade 2 or greater
No other currently active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix (previously treated malignancy allowed if considered to be at less than 30% risk of relapse)
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No other concurrent uncontrolled illness
No colony-stimulating factors (CSFs) within 24 hours of study chemotherapy
No CSFs during first course of study therapy
No concurrent filgrastim-SD/01
No concurrent immunotherapy
See Disease Characteristics
At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin)
No other concurrent chemotherapy
No concurrent hormonal therapy
At least 4 weeks since prior radiotherapy
No concurrent therapeutic radiotherapy
At least 4 weeks since prior surgery
Recovered from prior therapy
At least 7 days since prior cimetidine
No concurrent cimetidine
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent anticancer medications
No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum
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| Name | Affiliation | Role |
|---|---|---|
| Sonali Smith | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| M D Anderson Cancer Center |
One patient never received treatment and was excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (Chemosensitive) | Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| up to 3 years |
| Overall Survival | Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive. | up to 3 years |
| Time to Progression | Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy. | up to 3 years |
| Houston |
| Texas |
| 77030 |
| United States |
| Cohort 2 (Chmoresistant) |
Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy. |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (Chemosensitive) | Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy. |
| BG001 | Cohort 2 (Chmoresistant) | Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| LDH elevation | Number | Participants |
| ||||||||||||||||
| Prior therapies | Number | Participants |
| ||||||||||||||||
| Prior rituximab | Number | Participants |
|
| 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 | Objective Overall Response Rate | The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR. | Posted | Number | participants | up to 3 years |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Safety and Toxicity of Ixabepilone | Number of patients experiencing adverse event grade 3 or above. Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Adverse events possibly, probably, or definitely attributed to use of ixabepilone. | Posted | Number | participants | up to 3 years |
|
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| Secondary | Duration of Response | Duration of response was measured from the time measurement criteria are met for CR(complete response)/CRu(unconfirmed complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the 1999 international response criteria as published by Cheson, CR/CRu is defined as the disappearance of all target lesions; PR is defined as >=50% decrease in the sum of the products of the greatest diameters; PD is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy. | Posted | Median | 95% Confidence Interval | Days | up to 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive. | Posted | Median | 95% Confidence Interval | Days | up to 3 years |
|
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| Secondary | Time to Progression | Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy. | Posted | Median | 95% Confidence Interval | Days | up to 3 years |
|
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Adverse events possibly, probably, or definitely attributed to use of ixabepilone. The Adverse event report includes all patients experiencing adverse events with any grade while one of the primary outcomes (safety and toxicity of Ixabepilone) targeted patients experiencing adverse event grade 3 or above.
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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 | Ixabeilone for Relapsed Aggressive NHL | 11 | 51 | 48 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sonali M. Smith | University of Chicago Medical Center | 773-834-2895 | smsmith@medicine.bsd.uchicago.edu |
| ID | Term |
|---|---|
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
Not provided
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| Male |
|
| African American |
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| Hispanic |
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| No |
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| 2-3 |
|
| 4 or more |
|
| No |
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| Units | Counts |
|---|---|
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| Units | Counts |
|---|---|
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