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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
| Columbia University | OTHER |
| Dana-Farber Cancer Institute | OTHER |
Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.
This is a randomized phase II study that will test two different adjuvant temozolomide regimens in patients with newly diagnosed glioblastoma multiforme. The goal of this study is to identify a regimen that would be appropriate to bring to a phase III trial and compare to the standard dosing regimen of temozolomide recently reported by Stupp et al. in the New England Journal of Medicine. Secondary goals of this study include: prospective analysis of the prognostic impact of MGMT status and generation of preliminary data regarding this treatment strategy for other types of malignant glioma.
The decision regarding which treatment patients receive is made randomly. Neither them or their doctor can select which treatment the patient will receive. There is reason to believe that both of these doses may benefit treating your brain tumor. After 6 months of chemotherapy, and assuming the brain tumor has not shown any sign of growth, they will begin receiving cis-retinoic acid. Cis retinoic acid has been shown in one study to possibly prevent or delay tumor recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronomic Therapy Cohort | Active Comparator | Concurrent temozolomide and radiotherapy plus lose dose of temozolomide |
|
| Dose-Dense Therapy Cohort | Experimental | Concurrent temozolomide and radiotherapy plus high dose of temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression. |
| Measure | Description | Time Frame |
|---|---|---|
| 12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid. | until death or date of last follow up, an average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival at 6 Months | 6 months | |
| Prognostic Impact of Methylated MGMT Status. | MGMT promoter methylation is currently considered the main prognostic biomarker in glioblastoma. Methylation MGMT status will be assessed using real-time PCR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa DeAngelis, M.D | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan-Kettering Cancer Center at Commack |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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85 participants had a Glioblastoma diagnosis.
The remaining participants consist of an exploratory cohort of Grade 3 tumors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metronomic Therapy Cohort | Concurrent temozolomide and radiotherapy plus lose dose of temozolomide Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression. |
| FG001 | Dose-Dense Therapy Cohort | Concurrent temozolomide and radiotherapy plus high dose of temozolomide Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metronomic Therapy Cohort | Concurrent temozolomide and radiotherapy plus lose dose of temozolomide Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid. | Posted | Number | percentage of participants | until death or date of last follow up, an average of 12 months |
|
1 year
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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 | Metronomic Therapy Cohort | Concurrent temozolomide and radiotherapy plus lose dose of temozolomide Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bilirubin | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Deangelis | Memorial Sloan Kettering Cancer Center | 212-639-7997 | deangell@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2011 | Jan 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
| Temozolomide | Drug | Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression. |
|
| through study completion, an average of 1 year |
| To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes. | through study completion, an average of 1 year |
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| BG001 | Dose-Dense Therapy Cohort | Concurrent temozolomide and radiotherapy plus high dose of temozolomide Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Dose-Dense Therapy Cohort |
Concurrent temozolomide and radiotherapy plus high dose of temozolomide Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression. |
|
|
| Secondary | Progression Free Survival at 6 Months | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Prognostic Impact of Methylated MGMT Status. | MGMT promoter methylation is currently considered the main prognostic biomarker in glioblastoma. Methylation MGMT status will be assessed using real-time PCR. | Data were not collected | Posted | through study completion, an average of 1 year |
|
|
| Secondary | To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes. | Data were not collected | Posted | through study completion, an average of 1 year |
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 43 |
| 43 |
| EG001 | Dose-Dense Therapy Cohort | Concurrent temozolomide and radiotherapy plus high dose of temozolomide Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression. | 1 | 42 | 0 | 42 | 42 | 42 |
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Alkaline Phosphatase | Investigations | Systematic Assessment |
|
| ALT | Investigations | Systematic Assessment |
|
| Lymphopenia | Investigations | Systematic Assessment |
|
| PTT | Investigations | Systematic Assessment |
|
| Muscle weakness - right sided | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle weakness - Left sided | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle weakness extremity - lower | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| AST | Investigations | Systematic Assessment |
|
| Platelets | Investigations | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Creatinine | Investigations | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| INR | Investigations | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | Systematic Assessment |
|
| ANC | Investigations | Systematic Assessment |
|
| Hypomagnesmia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Amylase | Investigations | Systematic Assessment |
|
| Lipase | Investigations | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Edema: limb | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Hypercholesterolemia | Investigations | Systematic Assessment |
|
| Speech impairment | Nervous system disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |