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Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas


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

Thank you

Trial Information

Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas


OBJECTIVES:

- Evaluate the efficacy of recombinant interferon alpha (IFN alpha) as a single agent in
the treatment of recurrent unresectable meningiomas and malignant meningiomas.

- Determine the nature and extent of central nervous system (CNS) toxicities associated
with the use of alpha interferon in current doses and schedules.

OUTLINE: This is a two arm, randomized study. The first arm includes all histologically
benign meningiomas. The second arm includes all other pathologies.

All patients receive INF alpha as a subcutaneous injection Monday through Friday for 8
weeks. Treatment continues without interruption as long as there is no tumor recurrence or
progression and toxicity is acceptable.

Treatment continues without dose adjustment for the first 8 weeks as long as there are no
toxic effects of grade III or greater. Dosage for subsequent courses is one dose level below
the dose that produced toxicity of grade III or greater.

PROJECTED ACCRUAL: 20 patients will be entered per year into each arm.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven tumors:

- Unresectable meningioma

- Atypical meningioma

- Malignant meningioma

- Angioblastic meningioma

- Hemangiopericytoma

- Recurrent or progressive, unresectable tumor after failing radiation therapy or
refused radiation therapy following 2 surgeries

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- Karnofsky at least 60%

Life expectancy:

- At least 3 months

Hematopoietic:

- AGC at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- SGPT less than 2.0 times normal

- Alkaline phosphatase less than 2.0 times normal

- Bilirubin less than 1.5 mg/dL

Renal:

- BUN less than 1.5 times normal OR

- Creatinine less than 1.5 times normal

Other:

- No active infection

- No diseases that obscure toxicity or dangerously alter drug metabolism

- No serious intercurrent medical illness

- Not pregnant

- Fertile patients must use adequate contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent biologic therapy

Chemotherapy:

- Prior chemotherapy allowed and recovered from all myelotoxicity secondary to the
therapy

Endocrine therapy:

- Prior hormonal therapy allowed

- No concurrent hormonal therapy

Radiotherapy:

- Prior radiotherapy allowed

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Dose Limiting Toxicity (DLT)

Outcome Description:

Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).

Outcome Time Frame:

Each 8 weeks

Safety Issue:

No

Principal Investigator

Wai-Kwan A. Yung, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

DM96-296

NCT ID:

NCT00002965

Start Date:

January 1997

Completion Date:

March 2003

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • Meningioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009