Glioblastoma Clinical Trial
Official title:
A Randomized Phase II Trial of Concurrent Temozolomide and Radiotherapy Followed by Dose Dense Versus Metronomic Temozolomide and Maintenance Cis-Retinoic Acid for Patients With Newly Diagnosed Glioblastoma and Other Malignant Gliomas
Verified date | September 2016 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 127 |
Est. completion date | May 4, 2017 |
Est. primary completion date | May 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Pathologic evidence of a malignant glioma. - Tissue block or unstained slides must be available for MGMT analysis. - Age 18-70 - KPS > 50 - Granulocyte count >1.5 X 109/L - Platelet count >99 X 109/L - SGOT < 2.5X upper limit of normal (ULN). - Serum creatinine < 2X ULN. - Bilirubin < 2X ULN. - All patients must sign written informed consent. Exclusion Criteria: - Any prior chemotherapy, radiotherapy and biologic therapy for glioma. - Any prior experimental therapy for glioma. - Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin). - Serious medical or psychiatric illness that would in the opinion of the investigator would interfere with the prescribed treatment. - Pregnant or breast feeding women. - Refusal to use effective contraception. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering at Basking Ridge | Basking Ridge | New Jersey |
United States | Memorial Sloan-Kettering Cancer Center at Commack | Commack | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Columbia University, Dana-Farber Cancer Institute, Schering-Plough |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | until death or date of last follow up, an average of 12 months | ||
Secondary | Progression Free Survival at 6 Months | 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. | 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. | through study completion, an average of 1 year |
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