A Phase II Pilot Trial of Radiation Therapy With Concurrent and Adjuvant Temozolomide, Tamoxifen and Carboplatin (T2C) in the Treatment of Patients With Primary Central Nervous System Malignant Gliomas
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase II Pilot Trial of Radiation Therapy With Concurrent and Adjuvant Temozolomide, Tamoxifen and Carboplatin (T2C) in the Treatment of Patients With Primary Central Nervous System Malignant Gliomas
OBJECTIVES:
- Determine the progression-free and overall survival of patients with supratentorial
malignant gliomas (WHO grade III or IV) receiving radiotherapy with concurrent and
adjuvant temozolomide, tamoxifen citrate, and carboplatin.
- Determine the acute and delayed treatment-related toxicities in these patients.
- Determine tumor response in patients with postoperative measurable disease.
OUTLINE: This is an open-label, pilot study.
- Induction therapy: Patients receive oral temozolomide twice daily and oral tamoxifen
citrate twice daily on days 1-42 and carboplatin IV over 60 minutes on days 1, 8, 15,
22, 29, and 36. Patients also receive radiotherapy on days 1-5 in weeks 1-6.
- Consolidation therapy: Beginning 4 weeks after the completion of induction therapy,
patients receive temozolomide, tamoxifen citrate, and carboplatin as in induction
therapy. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme and/or anaplastic astrocytoma
- Supratentorial tumor
- No well-differentiated astrocytoma or glioma with oligodendroglial component
- No multifocal glioma
- Has undergone surgery within the past 6 weeks
- No recurrent glioblastoma multiforme
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Neurological functional status 0-2
- Life expectancy > 12 weeks
- ANC ≥ 1,200/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Blood urea nitrogen ≤ 1.5 times ULN
- Total and direct bilirubin ≤ 3 times ULN
- AST and ALT ≤ 3 times ULN
- Alkaline phosphatase ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
completion
- No other malignancies within the past 3 years, except for carcinoma in situ of the
cervix or nonmelanoma skin cancer
- No acquired immune deficiency syndrome (AIDS)
- No major medical illness or psychiatric impairment that would preclude study
compliance
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the head and neck
- No other concurrent therapy for the tumor
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Safety Issue:
No
Principal Investigator
Edward F. McClay, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
San Diego Pacific Oncology & Hematology Associates
Authority:
Unspecified
Study ID:
CDR0000551555
NCT ID:
NCT00492687
Start Date:
December 2006
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult anaplastic astrocytoma
- adult giant cell glioblastoma
- adult gliosarcoma
- adult glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Glioma
Name | Location |
|---|---|
| San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas | Encinitas, California 92024 |
