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Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
This study has been completed.
Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003463
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine
Drug: irinotecan hydrochloride
Drug: polifeprosan 20 with carmustine implant
Procedure: surgical procedure
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Carmustine Irinotecan Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1998
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 12 weeks

Hematopoietic:

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

Hepatic:

  • 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

Renal:

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

Neurological:

  • Must be neurologically stable

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003463

Locations
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
Investigators
Study Chair: Henry S. Friedman, MD Duke University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000066497, DUMC-0901-02-5R4, DUMC-0901-02-5R2, DUMC-000901-00-5R2, DUMC-000901-01-5R3, DUMC-0797-99-5RI, DUMC-796-98-5, DUMC-98065, UCLA-9812060, NCI-G98-1464, DUMC-0901-01-5R3
Study First Received: November 1, 1999
Last Updated: November 22, 2008
ClinicalTrials.gov Identifier: NCT00003463  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult brain stem glioma
adult glioblastoma
adult anaplastic astrocytoma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Irinotecan
Carmustine
Central Nervous System Neoplasms
Camptothecin
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009