Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer

Phase 2

Completed

• Conditions: Cervical Cancer; Esophageal Cancer; Head and Neck Cancer; Lung Cancer; Non-melanomatous Skin Cancer; Penile Cancer

• Registration Number: NCT00002506
• Lead Sponsor: Hoag Memorial Hospital Presbyterian

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent cancer or stop cancer from growing. Interferon alfa may interfere with the growth of cancer cells. Combining isotretinoin and interferon may be an effective treatment for some recurrent cancers.

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

Detailed Description

OBJECTIVES: I. Determine the response rates to treatment with daily subcutaneous interferon alpha plus oral isotretinoin in patients with advanced squamous cell carcinomas of the following body sites: head and neck, cervix, skin, esophagus, lung, and penis. II. Determine the toxicities and side effects of this treatment.

OUTLINE: Nonrandomized study. Single-agent Chemotherapy with Biological Response Modifier Therapy. Isotretinoin, 13-CRA, NSC-329481; with Interferon alpha (Schering or Hoffmann-La Roche), IFN-A, NSC-377523 or NSC-367982.

PROJECTED ACCRUAL: 14-50 patients per tumor category (and any other tumor location, if available) will be enrolled. If none of the first 14 patients in any tumor category responds, or if only 1/22, 2/30, 3/37, 4/44, or 5/50 respond, the treatment will be considered ineffective for that tumor type.

Study Timeline

• Study Start: 1992-08
• Primary Completion: 1996-01
• Study Completion: 1999-02
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-07-23
• Study First Posted: 2004-07-26
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-10
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Bloomington Hospital; 🇺🇸 Bloomington, Indiana, United States

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

St. Vincent Hospital and Health Care Center; 🇺🇸 Indianapolis, Indiana, United States

Baptist Regional Cancer Center - Knoxville; 🇺🇸 Knoxville, Tennessee, United States

St. Joseph Regional Cancer Center; 🇺🇸 Bryan, Texas, United States

Bergan Mercy Medical Center; 🇺🇸 Omaha, Nebraska, United States