Completed

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

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What is being tested

carmustine

+ irinotecan hydrochloride

+ polifeprosan 20 with carmustine implant

DrugProcedure
Who is being recruted

Brain Diseases+15

+ Central Nervous System Diseases

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 1998
See protocol details

Summary

Principal SponsorDuke University
Last updated: February 18, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003463
Principal SponsorDuke University
Last updated: February 18, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsNeuroectodermal TumorsNeoplasms, NeuroepithelialAstrocytomaBrain NeoplasmsGlioblastomaGliomaCentral Nervous System NeoplasmsGliosarcoma

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, United StatesOpen Jonsson Comprehensive Cancer Center, UCLA in Google Maps

Duke Comprehensive Cancer Center

Durham, United States
Completed2 Study Centers