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Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003463
Recruitment Status : Completed
First Posted : September 25, 2003
Last Update Posted : February 18, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: carmustine Drug: irinotecan hydrochloride Drug: polifeprosan 20 with carmustine implant Procedure: surgical procedure Phase 1

Detailed Description:


  • Define the maximum tolerated dose of irinotecan given in combination with Gliadel wafers (carmustine) in patients with recurrent glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma.
  • Define the toxicity of irinotecan given in combination with Gliadel wafers in these patients.

OUTLINE: This is a dose escalation study.

All patients undergo surgical resection. At the time of surgery, up to eight Gliadel wafers (containing carmustine) are implanted in the resected tumor cavity.

Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once weekly within 3 weeks after Gliadel wafer implantation. One course of treatment consists of 4 weeks of irinotecan and 2 weeks of rest. If 1 patient experiences dose limiting toxicity (DLT) at a dose level, an additional 3 patients are entered at that same dose level. If 2 patients experience DLT, the maximum tolerated dose (MTD) has been surpassed and a total of 6 patients are treated at the previous dose level. The MTD is defined as the highest dose in which no more than 1 of 6 patients experiences DLT.

Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease progression.

Patients are followed for at least 4 months.

PROJECTED ACCRUAL: Approximately 18 patients will be accrued into this study over 9 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)
Study Start Date : July 1998
Actual Primary Completion Date : July 2002
Actual Study Completion Date : July 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed recurrent supratentorial glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma
  • Must be able to undergo surgical resection
  • At least 1 bidimensionally measurable lesion documented on Gd-MRI within 72 hours after surgical implantation of Gliadel wafers
  • Not requiring immediate radiotherapy



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 125,000/mm^3
  • Hematocrit at least 29%


  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT less than 2.5 times ULN
  • Alkaline phosphatase less than 2 times ULN


  • BUN less than 1.5 times ULN
  • Creatinine less than 1.5 times ULN


  • Must be neurologically stable


  • HIV negative

    • No AIDS-related illness
  • No nonmalignant systemic disease that would make patient a poor medical risk
  • No acute infection requiring intravenous antibiotics
  • Not pregnant or nursing

    • Negative pregnancy test 24 hours prior to study
  • Effective contraception required of all fertile patients


Biologic therapy:

  • Not specified


  • No prior irinotecan
  • At least 6 weeks since chemotherapy unless there is unequivocal evidence of tumor progression after chemotherapy

Endocrine therapy:

  • At least 1 week of nonincreasing dose of steroids prior to study


  • At least 6 weeks since radiotherapy unless there is unequivocal evidence of tumor progression after radiotherapy
  • No concurrent radiotherapy


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003463

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
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Study Chair: Henry S. Friedman, MD Duke Cancer Institute
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Responsible Party: Duke University Identifier: NCT00003463    
Other Study ID Numbers: 0901
CDR0000066497 ( Other Identifier: NCI )
First Posted: September 25, 2003    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013
Keywords provided by Duke University:
recurrent adult brain tumor
adult brain stem glioma
adult glioblastoma
adult anaplastic astrocytoma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents