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Phase I/II Trial Of Temozolomide And Carboplatin In Recurrent Glioblastoma Multiforme

Phase 1/Phase 2
18 Years
Not 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 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 and stabilization rate in patients treated with this
regimen at the MTD. VI. Determine the acute and long-term toxic effects of this regimen at
the MTD in these patients. VII. Determine the time to tumor progression and survival of
patients treated with this regimen.

OUTLINE: This is a dose-escalation study. Patients are stratified according to age (under 50
vs 50 and over), ECOG performance status (0 vs 1-2), and prior therapy with carmustine or
lomustine (yes vs no). Patients receive carboplatin IV over 30 minutes on day 1 and oral
temozolomide on days 1-5. Treatment repeats every 4 weeks for a total of 6 courses in the
absence of disease progression or unacceptable toxicity. Patients with stable or responsive
disease may receive 6 additional courses of temozolomide. Cohorts of 1-6 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 at least 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. Additional patients are treated at the MTD.

PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for phase I of this study. A
total of 16-58 patients will be accrued for phase II of this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent glioblastoma multiforme
Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3 Platelet count
greater than 100,000/mm3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin no greater than
1.5 times normal SGOT no greater than 3 times upper limit of normal Renal: Creatinine
clearance greater than 50 mL/min Cardiovascular: No myocardial infarction within the past
6 months No congestive heart failure requiring therapy Other: HIV negative No active or
uncontrolled infection 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 No
frequent vomiting No medical condition that would interfere with oral medication intake
(e.g., partial bowel obstruction) No known or suspected psychiatric disorder that would
preclude study No other severe concurrent disease that would preclude study Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
during and for at least 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF) No
concurrent prophylactic filgrastim (G-CSF) Chemotherapy: No prior temozolomide No prior
platinum-based chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified
Surgery: Recovered from prior major surgery No more than 2 weeks since prior subtotal
tumor resection Other: Recovered from prior therapy No other concurrent investigational

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Jon Glass, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

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