Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	CBRG-9208 NBSG-9208, NCI-V92-0159, NCT00002506

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.

Entry 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

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

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

Expected Enrollment

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.

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.

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.

Trial Contact Information

Trial Lead Organizations

Cancer Biotherapy Research Group

Robert Dillman, MD, FACP, Protocol chair(Contact information may not be current)		Ph: 949-760-5543

Registry Information
Official Title		ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS
Trial Start Date		1992-08-03
Registered in ClinicalTrials.gov		NCT00002506
Date Submitted to PDQ		1992-08-03
Information Last Verified		2000-07-01

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