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Home > "P" Clinical Trials Conditions > PSA Vaccine or Nilutamide to Treat Advanced Prostate Cancer  PSA Vaccine or Nilutamide to Treat Advanced Prostate Cancer
PSA Vaccine or Nilutamide to Treat Advanced Prostate Cancer
For Condition: Prostate Neoplasm,Prostate Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will compare the effectiveness of the drug nilutamide with that of an experimental vaccine in controlling advanced prostate cancer. Nilutamide (Nilandron) is an anti-androgen approved for treating prostate cancer. The vaccine is composed of the following parts: rV-PSA - vaccinia virus plus human DNA that produces PSA (prostate specific antigen); rV-B7.1 - vaccinia virus plus human DNA that produces B7.1 (a protein that helps guide immune cells to their targets); rF-PSA - fowlpox virus plus human DNA that produces PSA; and GM-CSF and IL-2 - drugs that boost the immune system. Patients 18 years or older who have advanced prostate cancer that has not responded to hormonal therapy and who have been vaccinated against smallpox may be eligible for this study. Patients must have a rising PSA level but no X-ray evidence of tumor spread to other parts of the body. Candidates will be screened with X-rays, CT and MRI scans, skin tests similar to those for allergy or tuberculosis testing, and blood tests. Participants will be randomly assigned to one of the following treatment groups: 1. Vaccination - Patients in this group will receive the vaccine in 28-day treatment cycles, delivered in five parts during each cycle, as follows: GM-CSF on days 1 through 4; IL-2 days 8 through 12; rV-PSA and rV-B7.1 day 2; and rF-PSA days 30, 58, 86, etc. (i.e., every 4 weeks, beginning 4 weeks after the first rV-PSA and rV-B7.1 injection). The vaccinations are injected under the skin of the upper arm. Treatment will continue as long as the cancer is controlled and there are no serious side effects. Patients will have 15 cc (one tablespoon) of blood drawn once a week for the first month and then 60 cc (4 tablespoons) once every 4 weeks. Scans and X-rays will be done after 3 months, 6 months, and then every 2 months. Patients who, after 6 months, have a rising PSA level but no X-ray evidence of disease progression will be offered the option of switching to nilutamide therapy. 2. Nilutamide - Patients in this group will take the hormone by mouth, 6 tablets per day for the first month and 3 tablets per day thereafter. Treatment will continue as long as the cancer is controlled and there are no serious side effects. Patients will have 15 cc (one tablespoon) of blood drawn once a week for the first month and then 60 cc (4 tablespoons) once every 4 weeks. Patients who, after 6 months, have a rising PSA level but no X-ray evidence of disease progression will be offered the option of switching to vaccine therapy. All patients will have HLA tissue typing at the beginning of the study. Those who are type HLA-A2 will be asked to undergo the following additional procedures, which enable studies of the immune response that can be done only with this tissue type. - Lymphapheresis - A procedure similar to donating whole blood, but requiring 2 to 3 hours. In lymphapheresis, the blood is separated into its components by a machine, the lymphocytes (a type of white blood cell) are removed, and the rest of the blood is returned to the body. - Blood collection (60 cc) every 4 weeks - Prostate biopsy - Removal of a small sample of tumor tissue, done under local anesthetic.
Details: This trial will evaluate the efficacy and immunologic effects of a vaccination regimen composed of (1) recombinant vaccinia virus that expresses the Prostate Specific Antigen gene (rV-PSA) admixture, (2) recombinant vaccinia virus that expresses B7.1 costimulatory admixture (rV-B7.1), and (3) sequential vaccinations with recombinant fowlpox virus containing the PSA gene (rF-PSA) compared to the efficacy of antiandrogen therapy with Nilutamide in patients with hormone refractory prostate cancer with increasing PSA levels but with no radiographic evidence of metastatic disease. Patients randomized to the vaccine arm will in addition receive GM-CSF and IL-2 as part of their vaccination schedule. Patients will continue therapy monthly until there is radiographic evidence of metastatic disease. Patients without disease progression after 12 cycles, will receive the vaccine regimen every 12 weeks, until there is radiographic evidence of metastatic disease. The primary endpoint is to identify progression of disease at six months to determine if there is a statistically significant difference in time to progression. At any interval at or after this 6 month time point, patients with a rising PSA without radiographic evidence of disease progression, will be offered the option to begin therapy with the treatment offered in the other arm in addition to the treatment to which they were randomized. Serum Immunologic markers and PSA levels will be followed as secondary endpoints while patients continue to receive treatment on the protocol. Patients with PSA-expressing adenocarcinoma of the prostate will be evaluated for eligibility that includes a history of prior vaccinia (as vaccine against smallpox) and immunocompetence.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with histologically confirmed diagnosis of adenocarcinoma of the prostate without evidence of metastatic disease on scans, who are hormone resistant with a rising PSA level. Hormone resistance is defined as a rising PSA S/P orchiectomy and /or while receiving at least one regimen of LHRH. Patients on antiandrogen therapy must undergo antiandrogen withdrawal for at least one month and still evidence a rising PSA. Following treatment with bicalutamide, patients must undergo withdrawal for at least 6 weeks and still evidence a rising PSA. Patients should have a serum PSA which has risen at least 0.5 ng/ml from a baseline on 2 successive evaluations, each at least 1 week apart, during and/or after treatment with hormonal therapy. Patients should have an absolute minimal PSA level greater than 1.0 ng/ml. Patients must have a bone scan and CT (or MRI) of the abdomen and pelvis and chest CT or x-ray that shows no evidence of metastatic disease. The scans must be completed within 6 weeks prior to the date of randomization. Prostascint or similar immune-labeled scans will not be considered to include or exclude evidence for metastatic disease. Prior to randomization, patients will undergo HLA typing and will be stratified as either HLA-A2 positive or HLA-A2 negative. All HLA-A2 patients randomized to the vaccine arm who have not undergone a prostatectomy will be encouraged to undergo U/S guided core biopsy of their prostate gland at the NIH Clinical Center within 8 weeks prior to beginning their vaccine therapy. All HLA-A2 patients who have undergone a prostate biopsy will be encouraged to undergo leukaphereses within 3 weeks prior to receiving their first vaccination. These patients will also be encouraged to undergo leukaphereses prior to their next two vaccinations. Zubrod (ECOG) performance must be 0-2. Age greater than or equal to 18 years. At least 4 weeks must have elapsed since the last prior radiation therapy, surgery, and/or hormonal therapy, at least 6 weeks must have elapsed since the last dose of bicalutamide, and the patient must be recovered from all acute toxicities of that therapy. No concurrent chemotherapy, biologic therapy, or homeopathic therapy with PC-SPES or genestein is permitted. Patients who progressed on LHRH agents must remain on that agent or undergo surgical castration. Patients who have not undergone orchiectomy must have a testosterone level drawn prior to treatment and the result must be less than or equal to 50 ng/ml. Patients must have received prior vaccinia (for smallpox immunization). For all patients, recollection and appropriate vaccination-site scar is sufficient evidence; otherwise, a physician certification of prior smallpox immunization will suffice. Detectable anti-vaccinia antibodies will serve as sufficient proof of prior vaccination for patients of any age. Screening for anti-vaccinia antibodies will be performed only in patients who don't meet the above criteria. There must be no history of allergy or untoward reaction to prior vaccination with vaccinia virus. Absolute lymphocyte count greater than or equal to 600/mm(3); platelets greater than or equal to 100,000/mm(3); hemoglobin greater than or equal to 8.0 grams/dl. Serum bilirubin less than or equal to 1.6 mg/dl, AST and ALT less than or equal to 4 times normal. The initial urine analysis for eligibility should be grade less than or equal to proteinuria, Grade 0 proteinuria, grade 0 hematuria, and no abnormal sediment. Serum creatinine less than or equal to 1.5mg/dl or a creatinine clearance greater than 60 ml/min. Patients may be eligible if the underlying cause of the abnormality is determined to be non-renal. Immunologic testing must be performed looking for a positive delayed type hypersensitivity skin testing (e.g., to mumps, candida, trichophyton and/or similar antigens). However, for patients with good performance status, there is little correlation between skin test response and the ability to respond to vaccine, thus a patient does not need a positive test to be eligible for enrollment on this protocol. Patients must understand and sign informed consent that explains the neoplastic nature of his disease. EXCLUSION CRITERIA: Patients should have no evidence of being immunocompromised as defined below: Due to impaired cellular immunity, HIV patients are at an increased risk of serious side effects from vaccinations with infectious agents; Other diagnosis of altered immune function, or autoimmune disease (autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematous, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, or active Graves' disease); Prior radiation therapy to greater than 50% of nodal groups; Prior splenectomy; Concurrent steroid use, except topical and inhaled steroids. The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least two weeks after vaccination, their close household contacts: persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g. atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves; pregnant or nursing women; children under 5 years of age; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection. Close household contact are those who share housing or have close physical contact. Other serious intercurrent illness. Patients with active infections are not eligible until the infection has cleared for at least three days. History of other malignant process (excluding squamous cell or basal cell carcinoma of the skin), unless that previous tumor was treated with curative intent and the patient has been in remission for at least three years. Patients with active or a history of CNS metastases are ineligible. Patients with a history of seizures, encephalitis, or multiple sclerosis are not eligible. Patients must not have a known allergy to eggs are not eligible.
Total Enrollment: 78
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000137; 00-C-0137
Study Start Date: May 25, 2000
Record last reviewed: May 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005759
Other Prostate Cancer Studies:
1. PSA-Based Vaccine and Radiotherapy to Treat Localized Prostate Cancer
2. PSA Vaccine or Nilutamide to Treat Advanced Prostate Cancer
3. A Phase I Trial of Oral Perifosine with Different Loading Schedules in Patients with Refractory Neoplasms
Related Studies:
Other Prostate Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
PSA Vaccine or Nilutamide to Treat Advanced Prostate Cancer
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