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.
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
- Conditions the study is for
- Cervical Cancer, Esophageal Cancer, Head and Neck Cancer
- 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
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.
- Conditions
- Cervical Cancer, Esophageal Cancer, Head and Neck Cancer, Lung Cancer, Non-melanomatous Skin Cancer, Penile Cancer
- 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.
- First posted26 Jul 2004 (estimated)
- Study startAug 1992
- Primary completionJan 1996
- Study completionFeb 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Biotherapy Research Group
- Investigators
- Robert O. Dillman, MD, FACP, Study chair, Cancer Biotherapy Research Group
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS
- ClinicalTrials.gov ID
- NCT00002506
- Acronym / sponsor ID
- CDR0000077957
- Conditions
- Cervical Cancer, Esophageal Cancer, Head and Neck Cancer, Lung Cancer, Non-melanomatous Skin Cancer, Penile Cancer
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Collaborators
- Cancer Biotherapy Research Group
- Study start
- Aug 1992
- Primary completion
- Jan 1996 (actual)
- Study completion
- Feb 1999 (actual)
- First posted
- 26 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| isotretinoin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
- Results publicationDillman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert O. Dillman, MD, FACP study chair
Cancer Biotherapy Research Group
6 sites in 1 country: see every site and its status.
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.