NCT00002506

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1992

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1992

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1996

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
Last Updated

May 12, 2011

Status Verified

May 1, 2011

Enrollment Period

3.4 years

First QC Date

November 1, 1999

Last Update Submit

May 10, 2011

Conditions

Cervical CancerEsophageal CancerHead and Neck CancerLung CancerNon-melanomatous Skin CancerPenile Cancer

Keywords

recurrent non-small cell lung cancerrecurrent esophageal cancerrecurrent cervical cancersquamous cell lung cancersquamous cell carcinoma of the skinrecurrent penile cancerrecurrent skin cancersquamous cell carcinoma of the esophaguscervical squamous cell carcinomapenile squamous cell carcinomarecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Interventions

recombinant interferon alfaBIOLOGICAL
isotretinoinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

Bloomington Hospital

Bloomington, Indiana, 47402, United States

Location

St. Vincent Hospital and Health Care Center

Indianapolis, Indiana, 46260, United States

Location

Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Baptist Regional Cancer Center - Knoxville

Knoxville, Tennessee, 37901, United States

Location

St. Joseph Regional Cancer Center

Bryan, Texas, 77802, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEsophageal NeoplasmsHead and Neck NeoplasmsLung NeoplasmsPenile NeoplasmsCarcinoma, Non-Small-Cell LungSkin NeoplasmsEsophageal Squamous Cell CarcinomaSquamous Cell Carcinoma of Head and Neck

Interventions

Interferon-alphaIsotretinoin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleGenital Diseases, MalePenile DiseasesMale Urogenital DiseasesCarcinoma, BronchogenicBronchial NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, Biological

Study Officials

  • Robert O. Dillman, MD, FACP

    Cancer Biotherapy Research Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 26, 2004

Study Start

August 1, 1992

Primary Completion

January 1, 1996

Study Completion

February 1, 1999

Last Updated

May 12, 2011

Record last verified: 2011-05

Locations

US(6)