NCT00002965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 11, 2003

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

6.2 years

First QC Date

November 1, 1999

Last Update Submit

December 21, 2023

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor

Outcome Measures

Primary Outcomes (1)

  • 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).

    Each 8 weeks

Study Arms (2)

Arm 1: Benign Meningiomas

EXPERIMENTAL

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

Biological: Recombinant Interferon Alfa (INF alpha)

Arm 2: Other Pathologies

EXPERIMENTAL

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

Biological: Recombinant Interferon Alfa (INF alpha)

Interventions

Recombinant Interferon Alfa (INF alpha)BIOLOGICAL

Subcutaneous injection Monday through Friday for 8 weeks.

Also known as: Roferon, Interferon Alfa, Alpha 2 Interferon, IFN alpha-2A, IFN-Alpha 2, Interferon alfa 2a, Recombinant Interferon Alfa-2a
Arm 1: Benign MeningiomasArm 2: Other Pathologies

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain Neoplasms

Interventions

Interferon-alphaInterferon alpha-2

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Wai-Kwan A. Yung, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 11, 2003

Study Start

January 1, 1997

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

December 22, 2023

Record last verified: 2023-12

Locations

US(1)