Completed

Recombinant Interferon-Alpha in Recurrent Unresectable and Malignant Meningiomas Treatment

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Study Aim

This phase 2 study aims to evaluate the safety and effectiveness of Recombinant Interferon-Alpha as a single agent treatment for recurrent unresectable and malignant meningiomas, specifically by measuring the number of patients with Dose Limiting Toxicity (DLT).

What is being tested

Weekly INF Alpha Injections for 8 Weeks

+ Weekly INF Alpha Injections for 8 Weeks

Biological
Who is being recruted

Brain Diseases+5

+ Central Nervous System Diseases

+ Neoplasms

Over 16 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 1997
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: December 22, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00002965
Principal SponsorM.D. Anderson Cancer Center
Last updated: December 22, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsBrain NeoplasmsCentral Nervous System Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Texas - MD Anderson Cancer Center

Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps
CompletedOne Study Center