Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450463 |
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, may lessen the amount of androgens made by the body. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving flutamide together with vaccine therapy may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying flutamide and vaccine therapy to see how well they work compared with flutamide alone in treating patients with nonmetastatic prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: flutamide Drug: recombinant fowlpox-prostate apecific antigen vaccine Drug: recombinant vaccinia prostate-specific antigen vaccine Drug: sargramostim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized Phase II Trial Combining Vaccine Therapy With Prostvac/Tricom and Flutamide, Vs Flutamide Alone in Men With Androgen Insensitive, Non Metastatic (D0.5) Prostate Cancer |
Estimated Enrollment: | 70 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Active Comparator
Patients receive flutamide orally 3 times a day on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels) without metastatic disease (as evidenced on scans), may receive vaccine treatment as defined in arm II beginning 4 weeks after flutamide therapy is discontinued.
|
Drug: flutamide
Given orally
|
Arm II: Experimental
Patients receive flutamide orally 3 times a day on days 1-28. Patients also receive recombinant vaccinia PSA vaccine subcutaneously (SC) on day 1 of course 1 only and recombinant fowlpox PSA vaccine SC on day 1 of all subsequent courses. Patients receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels), discontinue flutamide but may continue to receive vaccine treatment.
|
Drug: flutamide
Given orally
Drug: recombinant fowlpox-prostate apecific antigen vaccine
Given subcutaneously
Drug: recombinant vaccinia prostate-specific antigen vaccine
Given subcutaneously
Drug: sargramostim
Given subcutaneously
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, pilot, crossover study. Patients are stratified according to prostate-specific antigen (PSA) doubling time (> 10 months vs ≤ 10 months) using the last two PSA values 1 month apart prior to enrollment on study. Patients are randomized to 1 of 2 treatment arms.
After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels) without metastatic disease (as evidenced on scans), may receive vaccine treatment as defined in arm II beginning 4 weeks after flutamide therapy is discontinued.
After 3 months of treatment, patients who do not develop clinical progression, but develop biochemical recurrence (e.g., rising PSA levels), discontinue flutamide but may continue to receive vaccine treatment.
All patients undergo blood collection periodically for immunological studies. Blood serum is analyzed for interferon gamma-releasing T-cells specific to PSA-3A, as measured by ELISPOT assay, as well as antibodies to PSA, vaccinia, fowlpox, and antinuclear antibody titer by immunoenzyme techniques.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Nonmetastatic disease
Androgen-insensitive disease meeting the following criteria:
PATIENT CHARACTERISTICS:
No evidence of being immunocompromised, including any of the following:
No autoimmune diseases that required treatment, including any of the following:
No concurrent serious medical illness (e.g., one that requires treatment) that would preclude study treatment including, but not limited to, any of the following:
Must be able to avoid close contact (e.g., share the same house or has close physical contact) with any of the following individuals for ≥ 3 weeks after treatment with the study vaccine:
Individuals with other active, chronic, or exfoliative skin conditions, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior or concurrent systemic steroids
No concurrent therapy, including any of the following:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | James Gulley, MD, PhD | National Cancer Institute (NCI) |
Study Chair: | Ravi Madan, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000535593, NCI-07-C-0107 |
Study First Received: | March 20, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00450463 |
Health Authority: | Unspecified |
stage I prostate cancer stage II prostate cancer stage III prostate cancer recurrent prostate cancer stage IV prostate cancer |
Metronidazole Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Flutamide Genital Diseases, Male Prostatic Neoplasms Recurrence |
Androgen Antagonists Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents |
Hormone Antagonists Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |