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Phase I/II Trial of Temozolomide and Carboplatin in Recurrent Glioblastoma Multiforme

Phase 1/Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

Phase I/II Trial of Temozolomide and Carboplatin in Recurrent Glioblastoma Multiforme

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of temozolomide and carboplatin in
patients with recurrent glioblastoma multiforme. II. Determine the acute and long-term toxic
effects of this regimen in these patients. III. Determine the pharmacokinetics of this
regimen in these patients. IV. Determine the potential of either a pharmacokinetic- or
pharmacodynamic-mediated drug interaction in patients treated with this regimen. V.
Determine the objective response rate in patients treated with the established MTD of this
regimen. VI. Determine time to tumor progression and survival in patients treated with this

OUTLINE: This is a dose-escalation study. Patients are stratified according to prior
nitrosourea-based chemotherapy (yes vs no). Patients receive carboplatin IV over 30 minutes
on day 1 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for a
maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with a persistent response may continue to receive temozolomide only for an
additional 6 courses. Cohorts of 3-6 patients receive escalating doses of carboplatin and
temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, additional patients are accrued to receive carboplatin and
temozolomide at the recommended phase II dose.

PROJECTED ACCRUAL: A total of 13-70 patients (3-30 for phase I and 10-40 for phase II) will
be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent glioblastoma multiforme
Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky
70-100% Life expectancy: At least 15 weeks Hematopoietic: Granulocyte count greater than
1,500/mm3 Hemoglobin at least 10.0 g/dL Platelet count greater than 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3
times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial
infarction within the past 6 months No congestive heart failure requiring therapy Other:
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception HIV negative No active or uncontrolled infection No psychiatric disorders
that would preclude study No other severe concurrent disease that would preclude study No
frequent vomiting or other medical condition that would interfere with oral medication
administration (e.g., partial bowel obstruction) No other malignancy within the past 5
years except adequately treated basal cell or squamous cell skin cancer or carcinoma in
situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF)
Chemotherapy: No prior temozolomide No prior platinum-based chemotherapy Endocrine
therapy: Not specified Radiotherapy: Not specified Surgery: Recovered from prior major
surgery Other: Recovered from prior therapy No other concurrent investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael L. Gruber, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

December 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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