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Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer

Information source: Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cervical Cancer; Esophageal Cancer; Head and Neck Cancer; Lung Cancer; Non-melanomatous Skin Cancer; Penile Cancer

Intervention: recombinant interferon alfa (Biological); isotretinoin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hoag Memorial Hospital Presbyterian

Official(s) and/or principal investigator(s):
Robert O. Dillman, MD, FACP, Study Chair, Affiliation: Cancer Biotherapy Research Group


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.

Clinical Details


Study design: Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma that has failed standard local modalities for local disease and/or effective systemic therapy for metastatic disease, or for which other forms of systemic therapy have been refused Eligible sites include but are not limited to: Uterine cervix Head and neck Skin Esophagus Lung Penis Measurable or evaluable disease required Measurable disease defined as previously unirradiated disease reproducibly measurable in 2 dimensions by physical exam, x-ray, CT, MRI, or other radiologic procedure Documented progressive disease in a previously irradiated site is accepted as measurable Evaluable disease includes: Any visible radiologic disease not measurable in 2 perpendicular diameters Elevated squamous cell carcinoma antigen (SCCA) No active brain metastases Previously treated brain metastases that have responded to therapy do not exclude, but CNS disease is not considered measurable or evaluable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hct at least 30% Hepatic: Bilirubin less than 2. 0 mg/dl PT normal PTT normal Renal: Creatinine less than 2. 0 mg/dl Cardiovascular: No MI within 6 months No CHF requiring medication No arrhythmia requiring medication Pulmonary: Reasonable respiratory reserve required No requirement for supplemental oxygen No dyspnea at rest Other: No chronic underlying immunodeficiency disease No HIV positivity No pregnant patients (negative pregnancy test required) Adequate birth control required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No concomitant immunosuppressive drugs, e. g., cyclosporin Chemotherapy: At least 3 weeks since prior systemic chemotherapy with recovery Endocrine therapy: No concomitant corticosteroids Radiotherapy: No prior radiotherapy to measurable site unless disease progression is documented Surgery: Not specified

Locations and Contacts

Hoag Memorial Hospital Presbyterian, Newport Beach, California 92658, United States

Bloomington Hospital, Bloomington, Indiana 47402, United States

St. Vincent Hospital and Health Care Center, Indianapolis, Indiana 46260, United States

Bergan Mercy Medical Center, Omaha, Nebraska 68124, United States

Baptist Regional Cancer Center - Knoxville, Knoxville, Tennessee 37901, United States

St. Joseph Regional Cancer Center, Bryan, Texas 77802, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 1992
Last updated: May 10, 2011

Page last updated: August 23, 2015

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