Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy
together with temozolomide may kill more tumor cells. It is not yet known which schedule of
temozolomide when given together with radiation therapy is more effective in treating
glioblastoma or gliosarcoma.
PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide
to compare how well they work when given together with radiation therapy in treating patients
with newly diagnosed glioblastoma or gliosarcoma.
OBJECTIVES:
Primary
- Determine if dose-intensifying (increasing the "dose-density") the adjuvant temozolomide
component of the chemoradiation treatment enhances treatment efficacy as measured by
overall survival of patients with newly diagnosed glioblastoma or gliosarcoma.
Secondary
- Determine if dose-intensifying the adjuvant temozolomide component of the chemoradiation
treatment enhances treatment efficacy as measured by progression-free survival.
- Determine in patients with unmethylated MGMT (O-6-methylguanine-DNA methyltransferase)
if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment
enhances treatment efficacy (overall and progression-free survival) compared with
patients receiving conventional temozolomide dosing.
- Determine in patients with methylated MGMT if dose-intensifying the adjuvant
temozolomide component of the chemoradiation treatment enhances treatment efficacy
(overall and progression-free survival) compared with patients receiving conventional
temozolomide dosing.
- Determine if there is an association between tumor MGMT gene methylation status and
treatment response.
- Compare and record the toxicities of the conventional and dose-intense chemotherapy
regimens.
- Evaluate whether 6-month progression-free survival is associated with overall survival.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
recursive partitioning analysis class (III vs IV vs V), MGMT gene methylation status
(methylated vs nonmethylated vs indeterminate), and radiotherapy criteria used (standard vs
revised European).
After completion of study treatment, patients are followed every 3 months for 1 year, every 4
months for 2 years, and then every 6 months thereafter.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT00006080 -
Fenretinide in Treating Patients With Recurrent Malignant Glioma
|
Phase 2 | |
| Recruiting |
NCT00887146 -
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
|
Phase 3 | |
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Completed |
NCT00621686 -
Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme
|
Phase 2 | |
| Terminated |
NCT00227032 -
Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme
|
Phase 1 | |
| Completed |
NCT00112502 -
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
|
Phase 2 | |
| Terminated |
NCT00243022 -
Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
|
Phase 2 | |
| Active, not recruiting |
NCT00278278 -
Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas
|
Phase 3 | |
| Active, not recruiting |
NCT00087815 -
Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain
|
N/A | |
| Completed |
NCT00416819 -
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
|
N/A | |
| Completed |
NCT00052286 -
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
|
N/A | |
| Completed |
NCT00006093 -
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT00004129 -
Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
|
Phase 1 | |
| Completed |
NCT00004212 -
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT00003417 -
Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
|
Phase 1/Phase 2 | |
| Completed |
NCT00003464 -
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
|
Phase 2 | |
| Completed |
NCT00003173 -
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
|
Phase 2 | |
| Completed |
NCT00003484 -
Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
|
Phase 1 | |
| Completed |
NCT00003020 -
LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
|
Phase 1 |