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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00108732 |
Purpose
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy together with GM-CSF and, when needed, androgen ablation may be a more effective treatment for prostate cancer.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with prostate cancer that progressed after surgery and/or radiation therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: fowlpox-PSA-TRICOM vaccine Biological: sargramostim Biological: vaccinia-PSA-TRICOM vaccine Drug: bicalutamide Drug: goserelin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer |
| Estimated Enrollment: | 45 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive vaccinia-PSA-TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4 during weeks 1-4. Beginning in week 5, patients receive fowlpox-PSA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox-PSA-TRICOM vaccine and GM-CSF repeats every 4 weeks for 3 courses (weeks 5-16). Beginning in week 17, patients receive fowlpox-PSA-TRICOM vaccine and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.
Patients with biochemical or clinical disease progression receive androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox-PSA-TRICOM vaccine and GM-CSF. Treatment continues in the absence of further clinical or biochemical disease progression.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 10 years.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Tumor limited to the prostate
Hormone-sensitive disease
Evidence of prostate-specific antigen (PSA) progression after completion of definitive surgery and/or radiotherapy, as demonstrated by all of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No active autoimmune disease, including any of the following:
No other acute, chronic, or exfoliative skin condition, including any of the following:
Other
Must be able to avoid close contact (i.e., shares the same house or has close physical contact) with any of the following individuals for ≥ 3 weeks after treatment with the study vaccinia vaccine:
Individuals with other acute, chronic, or exfoliative skin condition, including any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 1 year since prior testosterone level-modulating therapy, including either of the following:
No concurrent systemic steroids
Local (e.g., topical, nasal, inhaled) steroids allowed
None of the following agents are allowed during the period in which the PSA levels are determined:
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Illinois | |
| Hematology and Oncology Associates | |
| Chicago, Illinois, United States, 60611 | |
| Mercy Hospital and Medical Center | |
| Chicago, Illinois, United States, 60616 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Midwest Center for Hematology/Oncology | |
| Joliet, Illinois, United States, 60432 | |
| Cancer Care and Hematology Specialists of Chicagoland - Niles | |
| Niles, Illinois, United States, 60714 | |
| Hematology Oncology Associates - Skokie | |
| Skokie, Illinois, United States, 60076 | |
| Hematology/Oncology of the North Shore at Gross Point Medical Center | |
| Skokie, Illinois, United States, 60076 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Iowa | |
| McCreery Cancer Center at Ottumwa Regional | |
| Ottumwa, Iowa, United States, 52501 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Robert S. DiPaola, MD | Cancer Institute of New Jersey |
| Investigator: | David Jarrard, MD | University of Wisconsin, Madison |
More Information
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00108732 History of Changes |
| Other Study ID Numbers: | CDR0000422430, ECOG-E9802 |
| Study First Received: | April 18, 2005 |
| Last Updated: | April 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Metronidazole Goserelin Bicalutamide Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |