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Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Cancer Biotherapy Research Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002506
  Purpose

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 Intervention Phase
Cervical Cancer
Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Non-Melanomatous Skin Cancer
Penile Cancer
Drug: isotretinoin
Drug: recombinant interferon alfa
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer Lung Cancer Skin Cancer
Drug Information available for: Isotretinoin Tretinoin Interferon alfa-n1 Interferon alfa-2a Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1992
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002506

Locations
United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
United States, Indiana
Bloomington Hospital
Bloomington, Indiana, United States, 47402
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
United States, Nebraska
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
United States, Tennessee
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States, 37901
United States, Texas
St. Joseph Regional Cancer Center
Bryan, Texas, United States, 77802
Sponsors and Collaborators
Cancer Biotherapy Research Group
Investigators
Study Chair: Robert O. Dillman, MD, FACP Cancer Biotherapy Research Group
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Dillman RO, Soori G, Tai DF, et al.: Interferon alpha-2A (FN) and cis-retinoic acid (CRA) for the treatment of squamous cell carcinoma (SCC): a preliminary report. J Immunother 20(5): 404, 1997.

Study ID Numbers: CDR0000077957, CBRG-9208, NBSG-9208, NCI-V92-0159
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002506  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Interferon Type I, Recombinant
Genital Neoplasms, Male
Gastrointestinal Diseases
Esophageal Neoplasms
Squamous cell carcinoma
Urogenital Neoplasms
Dental Caries
Respiratory Tract Diseases
Lung Neoplasms
Isotretinoin
Carcinoma, squamous cell
Laryngeal carcinoma
Penile Neoplasms
Neoplasms, Squamous Cell
Esophageal neoplasm
Interferon-alpha
Non-small cell lung cancer
Digestive System Neoplasms
Esophageal disorder
Skin Diseases
Interferons
Skin Neoplasms
Genital Diseases, Male
Recurrence
Carcinoma
Epidermoid carcinoma
Nasopharyngeal carcinoma
Digestive System Diseases
Head and Neck Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Penile Diseases
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 14, 2009