Trial record 3 of 14 for:    "Penile Neoplasms"

Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer

This study has been completed.
Sponsor:
Collaborator:
Cancer Biotherapy Research Group
Information provided by:
Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier:
NCT00002506
First received: November 1, 1999
Last updated: May 10, 2011
Last verified: May 2011
  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
Biological: recombinant interferon alfa
Drug: isotretinoin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS

Resource links provided by NLM:


Further study details as provided by Hoag Memorial Hospital Presbyterian:

Study Start Date: August 1992
Study Completion Date: February 1999
Primary Completion Date: January 1996 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hoag Memorial Hospital Presbyterian
Cancer Biotherapy Research Group
Investigators
Study Chair: Robert O. Dillman, MD, FACP Cancer Biotherapy Research Group
  More Information

Additional Information:
Publications:
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.

Responsible Party: Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier: NCT00002506     History of Changes
Other Study ID Numbers: CDR0000077957, CBRG-9208, NBSG-9208, NCI-V92-0159
Study First Received: November 1, 1999
Last Updated: May 10, 2011
Health Authority: United States: Federal Government

Keywords provided by Hoag Memorial Hospital Presbyterian:
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

Additional relevant MeSH terms:
Penile Neoplasms
Skin Neoplasms
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male

ClinicalTrials.gov processed this record on August 26, 2014