Clinical Trial: Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer

This study is no longer recruiting patients.

Sponsored by: Cancer Biotherapy Research Group
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
recurrent non-small cell lung cancer
recurrent cervical cancer
recurrent squamous cell carcinoma of the lip and oral cavity
cervical squamous cell carcinoma
squamous cell carcinoma of the skin
recurrent skin cancer
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent esophageal cancer
Squamous Cell Lung Cancer
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent penile cancer
penile squamous cell carcinoma
squamous cell carcinoma of the esophagus
recurrent squamous cell carcinoma of the larynx
 Drug: interferon alfa
 Drug: isotretinoin
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Esophageal Cancer;   Head and Neck Cancer;   Lung Cancer;   Male Genital Disorders;   Mouth Disorders;   Nasal Cancer;   Oral Cancer;   Reproductive Health;   Skin Cancer;   Soft Tissue Sarcoma;   Throat Disorders

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Trial of IFN-A/13-CRA in Patients with Recurrent Squamous Cell Carcinomas Including Those of the Cervix, Skin, Head and Neck, Esophagus, Lung, and Penis

Further Study Details: 

Study start: August 1992

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.

PROTOCOL 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 above

Criteria

PROTOCOL 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--

--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

Location Information


California
      Hoag Memorial Hospital Presbyterian, Newport Beach,  California,  92658,  United States

Indiana
      Bloomington Hospital, Bloomington,  Indiana,  47402,  United States

      St. Vincent Hospital and Health Care Center, Indianapolis,  Indiana,  46260,  United States

Nebraska
      Bergan Mercy Medical Center, Omaha,  Nebraska,  68124,  United States

Tennessee
      Baptist Regional Cancer Center - Knoxville, Knoxville,  Tennessee,  37901,  United States

Texas
      St. Joseph Regional Cancer Center, Bryan,  Texas,  77802,  United States

Study chairs or principal investigators

Robert O. Dillman,  Study Chair,  Cancer Biotherapy Research Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000077957; CBRG-9208; NCI-V92-0159; NBSG-9208
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002506
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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