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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003463
• Other study ID #: 0901
• Secondary ID: DUMC-0901-02-5R4
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: February 15, 2013
• Start date: July 1998
• Est. completion date: July 2002

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2002
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• carmustine

• irinotecan hydrochloride

• polifeprosan 20 with carmustine implant

Procedure:
• surgical procedure

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,