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| Sponsor: | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00217373 |
Purpose
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells that make carcinoembryonic antigen (CEA). Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Interferon alfa-2b may interfere with the growth of cancer cells and slow cancer growth. Giving vaccine therapy together with GM-CSF and interferon alfa-2b may kill more cancer cells that make CEA.
PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa-2b when given together with vaccine therapy and GM-CSF in treating patients with locally advanced or metastatic cancer that makes CEA.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine Biological: recombinant interferon alfa-2b Biological: recombinant vaccinia-CEA(6D)-TRICOM vaccine Biological: sargramostim |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Sequential Vaccinations With Fowlpox-CEA(6D)-Tricom (B7.1/ICAM/LFA3) and Vaccinia-CEA (6D)-Tricom, in Combination With GM-CSF and Interferon-Alfa-2B in Patients With CEA-Expressing Carcinomas |
| Estimated Enrollment: | 27 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of interferon alfa-2b (IFN-α-2b).
NOTE: *The initial cohort of 6 patients does not receive IFN-α-2b.
Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After 4 courses, patients who do not have progressive disease or unacceptable toxicity may receive recombinant fowlpox-CEA (6D)-TRICOM vaccine, GM-CSF, and IFN-α-2b every 28 days for 2 more courses and then every 3 months for up to 2 years.
Cohorts of 3-6 patients receive escalating doses of IFN-α-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Six additional patients are treated at the MTD; these patients must be HLA-A2 positive.
After completion of study treatment, patients are followed monthly for 4 months and then every 6-12 months for up to 15 years.
PROJECTED ACCRUAL: A minimum of 27 patients will be accrued for this study within 8-10 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoembryonic antigen (CEA)-expressing carcinoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No other acute, chronic, or exfoliative skin conditions, including any of the following:
Other
Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
Must be able to avoid close household contact with the following individuals for ≥ 3 weeks after vaccinia vaccination:
Individuals with the following conditions:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| Study Chair: | William E. Carson, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
| Study ID Numbers: | CDR0000439532, OSU-2005H0005, NCI-5633 |
| Study First Received: | September 20, 2005 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00217373 History of Changes |
| Health Authority: | Unspecified |
|
unspecified adult solid tumor, protocol specific |
|
Interferon-alpha Metronidazole Anti-Infective Agents Antiprotozoal Agents Interferon Type I, Recombinant Immunologic Factors Antineoplastic Agents Growth Substances Interferons Physiological Effects of Drugs |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Antiparasitic Agents Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Interferon Alfa-2a Interferon Alfa-2b |