Completed

ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS

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What is being tested

recombinant interferon alfa

+ isotretinoin

BiologicalDrug
Who is being recruted

Urogenital Diseases+40

+ Genital Diseases

+ Bronchial Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 1992
See protocol details

Summary

Principal SponsorHoag Memorial Hospital Presbyterian
Last updated: May 12, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1992

Actual date on which the first participant was enrolled.

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.

NCT00002506
Principal SponsorHoag Memorial Hospital Presbyterian
Last updated: May 12, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Squamous CellUterine Cervical DiseasesDigestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, FemaleGenital Diseases, MaleGenital Neoplasms, FemaleGenital Neoplasms, MaleLung DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialPenile DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesThoracic NeoplasmsUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsSkin and Connective Tissue DiseasesNeoplasms, Squamous CellFemale Urogenital DiseasesMale Urogenital DiseasesSquamous Cell Carcinoma of Head and NeckEsophageal Squamous Cell CarcinomaCarcinoma, Non-Small-Cell LungUterine Cervical NeoplasmsEsophageal NeoplasmsHead and Neck NeoplasmsLung NeoplasmsPenile NeoplasmsSkin Neoplasms

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Hoag Memorial Hospital Presbyterian

Newport Beach, United StatesOpen Hoag Memorial Hospital Presbyterian in Google Maps

Bloomington Hospital

Bloomington, United States

St. Vincent Hospital and Health Care Center

Indianapolis, United States

Bergan Mercy Medical Center

Omaha, United States
Completed6 Study Centers