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Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas

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ClinicalTrials.gov Identifier: NCT00002965
Recruitment Status : Completed
First Posted : July 11, 2003
Last Update Posted : July 30, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

November 1, 1999
July 11, 2003
July 30, 2012
January 1997
March 2003   (Final data collection date for primary outcome measure)
Number of Patients with Dose Limiting Toxicity (DLT) [ Time Frame: Each 8 weeks ]
Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).
Not Provided
Complete list of historical versions of study NCT00002965 on ClinicalTrials.gov Archive Site
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Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas
Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating patients with 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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
Biological: Recombinant Interferon Alfa (INF alpha)
Subcutaneous injection Monday through Friday for 8 weeks.
Other Names:
  • Roferon
  • Interferon Alfa
  • Alpha 2 Interferon
  • IFN alpha-2A
  • IFN-Alpha 2
  • Interferon alfa 2a
  • Recombinant Interferon Alfa-2a
  • Experimental: Arm 1: Benign Meningiomas
    INF alpha as a subcutaneous injection Monday to Friday for 8 weeks.
    Intervention: Biological: Recombinant Interferon Alfa (INF alpha)
  • Experimental: Arm 2: Other Pathologies
    INF alpha as subcutaneous injection Monday to Friday for 8 weeks.
    Intervention: Biological: Recombinant Interferon Alfa (INF alpha)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
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March 2003
March 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002965
DM96-296
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-DM-96296 ( Other Identifier: UT MD Anderson Cancer Center )
NCI-G97-1206
CDR0000065463 ( Registry Identifier: NCI PDQ )
No
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Wai-Kwan A. Yung, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP