Search / Trial NCT00002506

Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer

Launched by HOAG MEMORIAL HOSPITAL PRESBYTERIAN · Jul 23, 2004

Trial Information

Current as of December 07, 2024

Completed

Keywords

Recurrent Non Small Cell Lung Cancer Recurrent Esophageal Cancer Recurrent Cervical Cancer Squamous Cell Lung Cancer Squamous Cell Carcinoma Of The Skin Recurrent Penile Cancer Recurrent Skin Cancer Squamous Cell Carcinoma Of The Esophagus Cervical Squamous Cell Carcinoma Penile Squamous Cell Carcinoma Recurrent Squamous Cell Carcinoma Of The Lip And Oral Cavity Recurrent Squamous Cell Carcinoma Of The Oropharynx Recurrent Squamous Cell Carcinoma Of The Nasopharynx Recurrent Squamous Cell Carcinoma Of The Hypopharynx Recurrent Squamous Cell Carcinoma Of The Larynx Recurrent Squamous Cell Carcinoma Of The Paranasal Sinus And Nasal Cavity

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

Trial Officials

Robert O. Dillman, MD, FACP

Study Chair

Cancer Biotherapy Research Group

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.

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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