Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
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: isotretinoin (Drug); recombinant interferon alfa (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Cancer Biotherapy Research Group Official(s) and/or principal investigator(s):
Robert O. Dillman, MD, FACP, Study Chair, Affiliation: Cancer Biotherapy Research Group
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.
Clinical Details
Official title: ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS
Study design: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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 23, 2008
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