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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cervical Cancer, Esophageal Cancer, Head and Neck Cancer, Lung Cancer, Non-melanomatous Skin Cancer, Penile Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Biotherapy Research Group

Authority:

United States: Federal Government

Study ID:

CDR0000077957

NCT ID:

NCT00002506

Start Date:

August 1992

Completion Date:

February 1999

Related Keywords:

  • Cervical Cancer
  • Esophageal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Non-melanomatous Skin Cancer
  • Penile Cancer
  • 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
  • Skin Neoplasms
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Penile Neoplasms

Name

Location

Hoag Memorial Hospital PresbyterianNewport Beach, California  92658
Bloomington HospitalBloomington, Indiana  47402
Bergan Mercy Medical CenterOmaha, Nebraska  68124
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
St. Vincent Hospital and Health Care CenterIndianapolis, Indiana  46260
St. Joseph Regional Cancer CenterBryan, Texas  77802