Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-09

Study Completion Date

2017-05-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Super-Selective Intraarterial Cerebral Infusion Of Temozolomide (Temodar) For Treatment Of Newly Diagnosed GBM And AA

NCT01180816

Glioblastoma Multiforme Anaplastic Astrocytoma

COMPLETED PHASE1

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

NCT00304031

Brain and Central Nervous System Tumors

COMPLETED PHASE3

Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)

NCT00725010

Glioblastoma

COMPLETED

Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme

NCT01822275

Histologically Proven Diagnosis of Glioblastoma or Gliosarcoma (WHO Grade IV)

TERMINATED PHASE2

Radiation Therapy and Temsirolimus or Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

NCT01019434

Brain and Central Nervous System Tumors

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma Gliomas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metronomic Therapy Cohort

Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Group Type ACTIVE_COMPARATOR

Temozolomide

Intervention Type 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.

Dose-Dense Therapy Cohort

Concurrent temozolomide and radiotherapy plus high dose of temozolomide

Group Type EXPERIMENTAL

Temozolomide

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No