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Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer Clinical research trials and Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer. Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer  Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer
Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer
For Condition: recurrent prostate cancer,stage 4 prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a gene-modifiedvirus may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of vaccine therapy plus sargramostim with that of empty vector control (vaccine that is not gene-modified) and placebo sargramostim in treating patients who have metastaticandrogen-independentprostate cancer.
Details: OBJECTIVES: - Compare the safety and efficacy of vaccinia-PSA-TRICOM vaccine and fowlpox-PSA-TRICOM vaccine plus sargramostim (GM-CSF) vs empty vector control and placebo in patients with metastatic androgen-independent prostate cancer. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to bisphosphonate use (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive vaccinia-PSA-TRICOM vaccine subcutaneously (SC) on day 0 and fowlpox-PSA-TRICOM vaccine SC on days 14, 28, 56, 84, 112, and 140. Sargramostim (GM-CSF) is administered SC on days 0-3, 14-17, 28-31, 56-59, 84-87, 112-115, and 140-143. - Arm II (control): Patients receive empty vector SC on days 0, 14, 28, 56, 84, 112, and 140 and placebo SC on days 0-3, 14-17, 28-31, 56-59, 84-87, 112-115, and 140-143. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients in the control arm who have disease progression may receive vaccine and GM-CSF on an open-label extension of the study. PROJECTED ACCRUAL: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Metastatic disease confirmed by 1 of the following: - Lymph node metastasis measurable by CT scan - Bone metastasis evaluable by bone scan - Refractory to hormonal therapy - Evidence of 2 consecutive increases in prostate-specific antigen (PSA) documented at least 1 week apart, with 1 value at least 5 ng/mL - Prior small pox vaccination confirmed by 1 or more of the following: - Scar at the vaccination site - Patient verbalization - Written documentation - Prior military service - Castrate testosterone levels < 50 ng/dL, consistent with orchiectomy or continuous gonadotropin-releasing hormonal therapy (e.g., leuprolide or goserelin) - Gleason score 7 (at initial diagnosis) - No metastases to organs other than lymph nodes and bone PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute lymphocyte count 600/mm^3 - Platelet count > 100,000/mm^3 - WBC > 2,000/mm^3 - Hemoglobin 10 g/dL Hepatic - AST < 4 times upper limit of normal - Hepatitis B surface antigen negative - Hepatitis C surface antigen negative - Bilirubin < 2.0 mg/dL Renal - Creatinine < 2.0 mg/dL Cardiovascular - No significant cardiovascular abnormalities or diseases - No New York Heart Association class III or IV congestive heart failure - No myocardial infarction within the past 6 months - No unstable angina - No coronary angioplasty within the past 6 months - No uncontrolled atrial or ventricular arrhythmias Immunologic - HIV negative - No evidence of immunodeficiency or immune suppression - No autoimmune disease, including the following: - Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia - Systemic lupus erythematosus - Sjögren's syndrome - Scleroderma - Myasthenia gravis - Goodpasture's syndrome - Addison's disease - Hashimoto's thyroiditis - Active Graves disease - No allergy or untoward reaction to prior vaccinia (smallpox) vaccination - No allergy or untoward reaction to prior sargramostim (GM-CSF) - No hypersensitivity to eggs or egg products - No active infection within 72 hours of vaccination Other - Fertile patients must use effective contraception - Able to avoid close contact or household contact with the following high-risk individuals for 3 weeks after vaccination: - Children under the age of 5 - Pregnant or nursing women - Individuals with prior or concurrent extensive eczema or other eczematoid skin disorders - Immunocompromised individuals (by disease or therapy) such as those with AIDS - No uncontrolled clinically significant serious disease or organ system disorder - No prior or concurrent extensive eczema - No other acute, chronic, or exfoliative skin disorder, such as the following: - Extensive psoriasis - Burns - Impetigo - Disseminated zoster - Varicella zoster - Severe acne - Open rashes or wounds - No other malignancy within the past 2 years PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy or immunotherapy for cancer - No other concurrent biologic therapy or immunotherapy for cancer Chemotherapy - No prior chemotherapy for prostate cancer - No concurrent chemotherapy Endocrine therapy - See Disease Characteristics - More than 28 days since prior systemic corticosteroid therapy (except inhaled or topical steroids) - More than 42 days since prior antiandrogen therapy (e.g., bicalutamide, nilutamide, or flutamide) - More than 42 days since other prior hormonal therapy (e.g., ketoconazole) - No concurrent systemic steroid use Radiotherapy - More than 28 days since prior radiotherapy - No concurrent palliative radiotherapy - No concurrent strontium chloride Sr 89 therapy Surgery - See Disease Characteristics - No prior splenectomy Other - More than 28 days since prior investigational therapy - Concurrent bisphosphonate therapy allowed provided treatment was initiated at least 28 days prior to vaccination and remains at a constant level throughout study period - No concurrent immunosuppressive therapy - No concurrent opioid analgesics for tumor-associated pain
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FairoozKabbinavar, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Fairooz Kabbinavar 310-206-0868
Additional Information:
Study ID Numbers: CDR0000358918; UCLA-0309014,THERION-TBC-PRO-002
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081120
Other Adenocarcinoma Of The Prostate Studies:
1. Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
2. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
3. R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
4. Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
5. Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy and Sargramostim Compared With Empty Vector Control in Treating Patients With Metastatic Androgen-Independent Prostate Cancer
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