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	Treatment or Intervention	Phase
recurrent non-small cell lung cancer recurrent cervical cancer recurrent squamous cell carcinoma of the lip and oral cavity cervical squamous cell carcinoma squamous cell carcinoma of the skin recurrent skin cancer recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the nasopharynx recurrent esophageal cancer Squamous Cell Lung Cancer recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent penile cancer penile squamous cell carcinoma squamous cell carcinoma of the esophagus recurrent squamous cell carcinoma of the larynx	Drug: interferon alfa  Drug: isotretinoin	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

California
      Hoag Memorial Hospital Presbyterian, Newport Beach,  California,  92658,  United States
Indiana
      Bloomington Hospital, Bloomington,  Indiana,  47402,  United States
      St. Vincent Hospital and Health Care Center, Indianapolis,  Indiana,  46260,  United States
Nebraska
      Bergan Mercy Medical Center, Omaha,  Nebraska,  68124,  United States
Tennessee
      Baptist Regional Cancer Center - Knoxville, Knoxville,  Tennessee,  37901,  United States
Texas
      St. Joseph Regional Cancer Center, Bryan,  Texas,  77802,  United States

Study chairs or principal investigators

Robert O. Dillman,  Study Chair,  Cancer Biotherapy Research Group   

Study ID Numbers:  CDR0000077957; CBRG-9208; NCI-V92-0159; NBSG-9208
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002506
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08