Clinical Trials Directory

Trials / Completed

CompletedNCT00002506

Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer

ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
—
Sponsor
Hoag Memorial Hospital Presbyterian · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALrecombinant interferon alfa
DRUGisotretinoin

Timeline

Start date
1992-08-01
Primary completion
1996-01-01
Completion
1999-02-01
First posted
2004-07-26
Last updated
2011-05-12

Locations

6 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00002506. Inclusion in this directory is not an endorsement.