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AzTrials

Cervical CancerPhase 2NCT00002506

Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer

A Phase 2 study testing recombinant interferon alfa and isotretinoin in people with Cervical Cancer and Esophageal Cancer, run by Hoag Memorial Hospital Presbyterian at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
recombinant interferon alfa and isotretinoin
How many people
Not given
Where
6 sitesUnited States
Study dates
Aug 1992to Feb 1999
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Bloomington Hospital

    Bloomington, Indiana, 47402

  • St. Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Baptist Regional Cancer Center - Knoxville

    Knoxville, Tennessee, 37901

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

  • Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
recombinant interferon alfa, isotretinoin
Keywords
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
Medical subject headings
Uterine Cervical Neoplasms, Esophageal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Penile Neoplasms, Carcinoma, Non-Small-Cell Lung, Skin Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon alfaBiological

  • isotretinoinDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2004 (estimated)
  2. Study startAug 1992
  3. Primary completionJan 1996
  4. Study completionFeb 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002506
Sponsor's protocol ID
CDR0000077957
Other IDs
CBRG-9208, NBSG-9208, NCI-V92-0159
Status last verified
May 2011
First submitted
1 Nov 1999
Last updated
12 May 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing recombinant interferon alfa and isotretinoin in people with Cervical Cancer and Esophageal Cancer, run by Hoag Memorial Hospital Presbyterian at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002506, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2011; AzTrials last refreshed its copy on 7 Nov 2026.

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