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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Recombinant Interferon Alfa (INF alpha)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: Benign Meningiomas

Arm 2: Other Pathologies

Arm Description

INF alpha as a subcutaneous injection Monday to Friday for 8 weeks.

INF alpha as subcutaneous injection Monday to Friday for 8 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 27, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002965
Brief Title
Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas
Official Title
Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Benign Meningiomas
Arm Type
Experimental
Arm Description
INF alpha as a subcutaneous injection Monday to Friday for 8 weeks.
Arm Title
Arm 2: Other Pathologies
Arm Type
Experimental
Arm Description
INF alpha as subcutaneous injection Monday to Friday for 8 weeks.
Intervention Type
Biological
Intervention Name(s)
Recombinant Interferon Alfa (INF alpha)
Other Intervention Name(s)
Roferon, Interferon Alfa, Alpha 2 Interferon, IFN alpha-2A, IFN-Alpha 2, Interferon alfa 2a, Recombinant Interferon Alfa-2a
Intervention Description
Subcutaneous injection Monday through Friday for 8 weeks.
Primary Outcome Measure Information:
Title
Number of Patients with Dose Limiting Toxicity (DLT)
Description
Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).
Time Frame
Each 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai-Kwan A. Yung, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center Website

Learn more about this trial

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

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