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Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00003467
First received: November 1, 1999
Last updated: June 19, 2013
Last verified: October 2009
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine
Drug: polifeprosan 20 with carmustine implant
Procedure: surgical procedure
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers

Resource links provided by NLM:


Further study details as provided by Duke University:

Estimated Enrollment: 68
Study Start Date: January 1998
Study Completion Date: February 2004
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.
  • Assess the toxicity of this therapy in these patients.

OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).

Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 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 primary low grade glioma including:

    • Fibrillary astrocytoma
    • Oligodendroglioma
    • Mixed glioma
  • Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Hematocrit greater than 29%
  • Absolute neutrophil count greater than 1500/mm^3
  • Platelet count greater than 125,000/mm^3

Hepatic:

  • SGOT less than 1.5 times upper limit of normal (ULN)
  • Bilirubin less than 1.5 times ULN

Renal:

  • Creatinine less than 1.5 mg/dL
  • BUN less than 25 mg/dL

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy unless disease progression

Endocrine therapy:

  • Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study)
  • No concurrent immunosuppressive agents

Radiotherapy:

  • At least 4 weeks since prior radiotherapy unless disease progression

Surgery:

  • Not specified

Other:

  • No other concurrent medication that may interfere with study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003467

Locations
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

Additional Information:
No publications provided

Responsible Party: Henry Friedman, MD, Duke UMC
ClinicalTrials.gov Identifier: NCT00003467     History of Changes
Other Study ID Numbers: 1706, DUMC-1706-02-9R5, DUMC-1706-01-9R4, DUMC-000693-00-4, DUMC-1509-97-10, DUMC-1568-98-10R1, DUMC-1706-00-9R3, DUMC-97131, NCI-G98-1470, CDR0000066503
Study First Received: November 1, 1999
Last Updated: June 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Duke University:
recurrent adult brain tumor
adult brain stem glioma
adult mixed glioma
adult anaplastic astrocytoma
adult pilocytic astrocytoma
adult oligodendroglioma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Carmustine
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014