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Vaccine Therapy in Treating Patients With Advanced Prostate Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Vaccine Therapy in Treating Patients With Advanced Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Advanced Prostate Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Advanced Prostate Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Vaccine Therapy in Treating Patients With Advanced Prostate Cancer. Vaccine Therapy in Treating Patients With Advanced Prostate Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Advanced Prostate Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Vaccine Therapy in Treating Patients With Advanced Prostate Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Advanced Prostate Cancer  Vaccine Therapy in Treating Patients With Advanced Prostate Cancer
Vaccine Therapy in Treating Patients With Advanced Prostate Cancer
For Condition: recurrent prostate cancer,adenocarcinoma of the prostate,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a person's prostate cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy in treating patients who have advanced prostate cancer.
Details: OBJECTIVES: - Determine the toxicity and maximum tolerated dose of recombinant fowlpox prostate-specific antigen (PSA) vaccine in patients with advanced adenocarcinoma of the prostate. - Determine whether vaccination with recombinant fowlpox-PSA vaccine is associated with antitumor activity in these patients. - Determine the efficacy of prime and boost regimens using recombinant fowlpox-PSA vaccine and recombinant vaccinia-PSA vaccine in these patients. - Compare the PSA-specific T-cell response in patients treated with recombinant fowlpox-PSA vaccine followed by recombinant vaccinia-PSA vaccine vs the same vaccines but in reverse order. OUTLINE: This is a randomized, open-label, multicenter, dose-escalation study of recombinant fowlpox prostate-specific antigen (PSA) vaccine. - Safety cohort: The first cohort of 3 patients receives vaccination with recombinant fowlpox-PSA vaccine intramuscularly (IM). Treatment repeats every 4 weeks for 3 courses. In the absence of unacceptable toxicity in the first cohort, the second cohort of 3 patients receives the same vaccine at the dose level immediately higher than the first cohort dose level. In the presence of unacceptable toxicity in the first cohort, the second cohort of 3 patients receives the same vaccine at a dose level lower than the first cohort dose level. The maximum tolerated dose (MTD) is the dose preceding that at which 1 of 6 patients experiences grade 3 or worse dose-limiting toxicity. Subsequent patients are assigned to one of two vaccination groups based on prior treatment with recombinant vaccinia-PSA vaccine: - Patients are randomized to one of two vaccination arms: - Arm I: Patients receive recombinant fowlpox-PSA vaccine IM at the MTD from the safety cohort every 4 weeks for 3 courses. Patients then receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2 courses. - Arm II: Patients receive the same vaccines as in arm I but in reverse order. - Group B (prior recombinant vaccinia-PSA vaccine): Patients receive treatment as in arm I, group A. - Groups A and B: Patients with stable or responding disease at 6 months after completion of vaccination therapy may continue treatment on the group and arm to which they were originally assigned. Treatment repeats every 6-9 months in the absence of disease progression. Patients are followed monthly. PROJECTED ACCRUAL: Approximately 6-86 patients (6 in the safety cohort, 15-20 per arm in group A, and approximately 10 in group B) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following: - Lymph node positive and prostate-specific antigen (PSA) at least 10 ng/mL - Bone scan positive and PSA at least 10 ng/mL - Prior radical prostatectomy with rising PSA and PSA at least 2 ng/mL - Prior radiotherapy and PSA at least 10 ng/mL - Prior cryosurgery and PSA at least 10 ng/mL - PSA criteria does not apply to patients who are assigned to group B of this study and were previously treated on vaccine trial DFCI-96079 - No symptomatic metastatic disease (no bony pain) - Complete HLA typing required PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0 or 1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 2,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL - SGPT less than 4 times upper limit of normal Renal: - Creatinine less than 4.0 mg/dL Immunologic: - No altered immune function such as eczema - No autoimmune diseases such as the following: - Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia - Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma - Myasthenia gravis - Goodpasture's syndrome - Addison's disease, Hashimoto's thyroiditis, or active Graves' disease - HIV negative - No allergy or untoward reaction to prior vaccinia (smallpox) vaccination - No hypersensitivity to eggs Other: - No prior or concurrent extensive eczema or skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster) - No other concurrent serious illness - No active infection requiring antibiotics until infection has cleared and antibiotics have been stopped for at least 3 days - Fertile patients must use effective contraception - No close contact or household contact with the following high-risk individuals for at least 2 weeks after each vaccination: - Children under age 5 - Pregnant or nursing women - Individuals with prior or concurrent extensive eczema or other eczematoid skin disorders - Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) - Immunodeficient or immunosuppressed individuals (by disease or therapy) such as those with HIV infection PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - See Endocrine therapy - Prior vaccinia (smallpox) immunization required - No other concurrent biologic therapy (e.g., interferon or interleukin) for cancer Chemotherapy: - No prior chemotherapy for metastatic disease - No concurrent anticancer chemotherapy Endocrine therapy: - No prior hormonal therapy for metastatic disease - Prior neoadjuvant hormonal therapy followed by prostatectomy or radiotherapy allowed - Patients previously treated with recombinant vaccinia-PSA vaccine may have hormonal therapy since discontinuing that treatment (Group B) - No concurrent hormonal therapy or steroids Radiotherapy: - See Disease Characteristics - See Endocrine therapy - No concurrent radiotherapy Surgery: - See Disease Characteristics - See Endocrine therapy - No prior splenectomy Other: - At least 3 days since prior antibiotics - No concurrent immunosuppressive treatment (e.g., after organ transplantation)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephEder, Study Chair, Dana-Farber/Harvard Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000067630; DFCI-98262,NCI-T98-0004
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005039
Other Adenocarcinoma Of The Prostate Studies:
1. Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients with Locally Advanced Prostate Cancer
2. SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
3. Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
4. Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
5. Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Vaccine Therapy in Treating Patients With Advanced Prostate Cancer
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