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Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

1706

NCT ID:

NCT00003467

Start Date:

January 1998

Completion Date:

February 2004

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult brain stem glioma
  • adult mixed glioma
  • adult anaplastic astrocytoma
  • adult pilocytic astrocytoma
  • adult oligodendroglioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710