Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer
Launched by HOAG MEMORIAL HOSPITAL PRESBYTERIAN · Jul 23, 2004
Trial Information
Current as of June 12, 2025
Completed
Keywords
ClinConnect Summary
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 categor...
Gender
ALL
Eligibility 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
About Hoag Memorial Hospital Presbyterian
Hoag Memorial Hospital Presbyterian is a leading healthcare institution located in Southern California, dedicated to providing high-quality patient care and advancing medical research. As a prominent sponsor of clinical trials, Hoag is committed to exploring innovative therapies and treatments that enhance patient outcomes and contribute to the broader medical community. With a focus on collaboration and ethical research practices, Hoag leverages its state-of-the-art facilities and a multidisciplinary team of experts to facilitate rigorous clinical investigations across various therapeutic areas, ensuring the highest standards of safety and efficacy in all trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Newport Beach, California, United States
Bloomington, Indiana, United States
Omaha, Nebraska, United States
Knoxville, Tennessee, United States
Indianapolis, Indiana, United States
Bryan, Texas, United States
Patients applied
Trial Officials
Robert O. Dillman, MD, FACP
Study Chair
Cancer Biotherapy Research Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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