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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03149 | Registry Identifier | Clinical Trial Reporting Program (CTRP) |
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RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of temozolomide.
Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a week for 3 weeks.
After completion of study treatment, patients are followed at 1 month, 2 months, and 3 months, and then every 3 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionation Radiotherapy+Temozolomide | Experimental | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide | Drug | Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose(MTD)of Temozolomide(TMZ) | This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels will be recommended for phase II evaluations of treatment effect. | up to 12-16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Neuroradiological Evidence of Tumor Recurrence or Progression | As a small phase I study, no inferential statistical tests of hypotheses are planned. Data collected will be providing descriptive summary statistics. However, these estimates will allow statistically sound experimental designs and sample size calculations for subsequent studies of therapeutic effect. | up to 12-16 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Ammirati, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24380758 | Result | Ammirati M, Chotai S, Newton H, Lamki T, Wei L, Grecula J. Hypofractionated intensity modulated radiotherapy with temozolomide in newly diagnosed glioblastoma multiforme. J Clin Neurosci. 2014 Apr;21(4):633-7. doi: 10.1016/j.jocn.2013.09.005. Epub 2013 Oct 3. |
| Label | URL |
|---|---|
| Jamesline | View source |
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Patients were enrolled between 2009 and 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1: 50 mg/m2 | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Hypofractionated radiation therapy | Radiation | Patients will undergo HIMRT |
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| Intensity-modulated radiation therapy | Radiation | Patients undergo HIMRT |
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| Survival Time | All patients will be followed to death. Active follow-up with disease evaluation with scans will be terminated if the patient's physician deems it in the patient's interest not to continue or upon patient request. | up to 2 years |
| Time Spent in a Karnofsky Performance Status of 60-100% | Time spent in a KPS ≥70 was calculated from the date of diagnosis of Karonofsky Performance Status decline (KPS<70) or censored at the last date the patient was known with KPS ≥70. The KPS higher scores indicates normal activity status. | up to 12-16 months |
| FG001 | Dose Level 2: 65 mg/m2 | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT |
| FG002 | Dose Level 3: 75 mg/m2 | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT |
| COMPLETED |
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| NOT COMPLETED |
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Glioblastoma multiforme (GBM) patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT |
| BG001 | Dose Level 2 | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT |
| BG002 | Dose Level 3 | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT |
| 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | patients |
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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 | Maximum Tolerated Dose(MTD)of Temozolomide(TMZ) | This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels will be recommended for phase II evaluations of treatment effect. | Posted | Number | mg/m^2 | up to 12-16 months |
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| Secondary | Time to Neuroradiological Evidence of Tumor Recurrence or Progression | As a small phase I study, no inferential statistical tests of hypotheses are planned. Data collected will be providing descriptive summary statistics. However, these estimates will allow statistically sound experimental designs and sample size calculations for subsequent studies of therapeutic effect. | Not Posted | up to 12-16 months | Participants | |||||||||||||||||||||||||||||||
| Secondary | Survival Time | All patients will be followed to death. Active follow-up with disease evaluation with scans will be terminated if the patient's physician deems it in the patient's interest not to continue or upon patient request. | Posted | Median | 95% Confidence Interval | months | up to 2 years |
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| Secondary | Time Spent in a Karnofsky Performance Status of 60-100% | Time spent in a KPS ≥70 was calculated from the date of diagnosis of Karonofsky Performance Status decline (KPS<70) or censored at the last date the patient was known with KPS ≥70. The KPS higher scores indicates normal activity status. | Kaplan-Meier analysis for time spent in a Karnofsky performance status (KPS) ≥70 | Posted | Median | 95% Confidence Interval | months | up to 12-16 months |
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The National Cancer Institute Common Terminology for Adverse Events (CTCAE) 3.0 was utilized for grading patients adverse events.
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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 | 50 mg/m2 | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT | 0 | 3 | 3 | 3 | ||
| EG001 | 65 mg/m2 | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT | 0 | 3 | 3 | 3 | ||
| EG002 | 75 mg/m2 | Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions. temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy. Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT Intensity-modulated radiation therapy: Patients undergo HIMRT | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Partial seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Motor deficits | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Numbness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Vision changes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
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| Memory deficits | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Stomach cramps | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| High ALT | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Low Calcium | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| High gluclose | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Thrombocytopenia | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mario Ammirati, MD | The Ohio State University Comprehensive Cancer Center | 614-293-1970 | Mario.Ammirati@osumc.edu |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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