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A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy


- Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients
with glioblastoma multiforme. (Phase I closed to accrual as of 6/24/02)

- Determine the toxic effects of this regimen in these patients.

- Determine the objective response in patients treated with the established MTD of this

- Determine time to tumor progression and survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study. Patients in the phase II portion of the study are
stratified according to age (under 60 vs 60 and over), ECOG performance status (0-1 vs 2),
and extent of resection (total vs subtotal). (Phase I closed to accrual as of 6/24/02)

Within 4 weeks of surgery, patients receive carboplatin IV over 30 minutes followed by
irinotecan IV over 90 minutes on day 1. Treatment repeats every 4 weeks for a maximum of 6
courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan 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 irinotecan at the
recommended phase II dose. (Phase I closed to accrual as of 6/24/02)

After chemotherapy, all patients undergo radiotherapy.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 24-107 patients (3-54 for phase I and 21-53 for phase II) will
be accrued for this study. (Phase I closed to accrual as of 6/24/02)

Inclusion Criteria


- Histologically confirmed glioblastoma multiforme

- Measurable disease

- No CNS metastases or carcinomatous meningitis



- 18 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 70-100%

Life expectancy:

- At least 12 weeks


- Granulocyte count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin at least 9.0 g/dL


- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver

- No known Gilbert's syndrome


- Creatinine no greater than 1.5 mg/dL


- No myocardial infarction within the past 6 months

- No congestive heart failure requiring therapy


- HIV negative

- No active or uncontrolled infection

- No psychiatric disorder that would preclude study

- 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 uncontrolled diabetes mellitus (i.e., random blood sugar of 200 mg or more)

- No other severe disease that would preclude study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- No prior immunotherapy or biologic therapy

- No concurrent sargramostim (GM-CSF)

- No concurrent filgrastim (G-CSF) with course 1

- No concurrent immunotherapy


- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Must have maintained a stable or decreasing dose of corticosteroids for 2 weeks prior
to study

- Concurrent corticosteroids for cerebral edema allowed

- No concurrent anticancer hormonal therapy


- No prior radiotherapy

- No concurrent radiotherapy


- At least 2 weeks since prior surgery


- No other concurrent investigational agent or participation on any other clinical

- No concurrent immunosuppressive drugs

- No concurrent phenobarbital or valproic acid

- No concurrent anticonvulsants except carbamazepine or gabapentin

- No concurrent prochlorperazine on day of irinotecan treatment

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:

May 1999

Completion Date:

Related Keywords:

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



NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016