Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer
|ClinicalTrials.gov Identifier: NCT00002506|
Recruitment Status : Completed
First Posted : July 26, 2004
Last Update Posted : May 12, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Esophageal Cancer Head and Neck Cancer Lung Cancer Non-melanomatous Skin Cancer Penile Cancer||Biological: recombinant interferon alfa Drug: isotretinoin||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Official Title:||ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS|
|Study Start Date :||August 1992|
|Actual Primary Completion Date :||January 1996|
|Actual Study Completion Date :||February 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002506
|United States, California|
|Hoag Memorial Hospital Presbyterian|
|Newport Beach, California, United States, 92658|
|United States, Indiana|
|Bloomington, Indiana, United States, 47402|
|St. Vincent Hospital and Health Care Center|
|Indianapolis, Indiana, United States, 46260|
|United States, Nebraska|
|Bergan Mercy Medical Center|
|Omaha, Nebraska, United States, 68124|
|United States, Tennessee|
|Baptist Regional Cancer Center - Knoxville|
|Knoxville, Tennessee, United States, 37901|
|United States, Texas|
|St. Joseph Regional Cancer Center|
|Bryan, Texas, United States, 77802|
|Study Chair:||Robert O. Dillman, MD, FACP||Cancer Biotherapy Research Group|