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A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate Clinical research trials and A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate. A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate  A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate
A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate
For Condition: Prostatic Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This trial will evaluate, in patients with metastatic prostate cancer, the tolerability, toxicities, efficacy, and immunologic effects of repeated vaccinations with a recombinant vaccinia virus that contains the Prostate Specific Antigen gene (PROSTVAC).
Details: This trial will evaluate, in patients with metastatic prostate cancer, the tolerability, toxicities, efficacy, and immunologic effects of repeated vaccinations with a recombinant vaccinia virus that contains the Prostate Specific Antigen gene (PROSTVAC). 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. We completed a phase I trial investigating the use of rV-CEA in adenocarcinomas of the GI tract, lung and breast. The toxicities encountered are local reactions to the vaccine. We did not encounter any myelosuppression or systemic autoimmune reaction. We would like to evaluate four doses to ensure safety and to decide a best biological dose. Six patients will receive 2.65 x 10(5) PFU and 2.65 x 10(6) PFU of vaccine by scarification. Because higher doses cannot be achieved by scarification, six patients will receive 2.65 x 10(7) PFU and 2.65 x 10(8) PFU subcutaneously. We plan to give three vaccinations at four week intervals. All six patients treated in each dose level must be evaluable for 4 weeks before enrolling patients at the higher dose level. No intrapatient escalation is planned. Toxicity, tumor response, and humoral and cellular immunity factors will be monitored. Optional lymphapheresis will be done on patients that are HLA A2. Once we determined the best biological dose, we would like to accrue an additional 6 patients to that level.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate as follows: Unresectable and/or incurable tumor AND Tumor progression after at least 1 prior hormonal manipulation (i.e., LHRH agonist/flutamide or orchiectomy). LHRH agonist may by continued concurrently with protocol therapy. New bone or soft tissue lesions OR Serum PSA that has risen on 3 successive evaluations at least 1 week apart during and/or after hormonal therapy. If PSA is below 4 ng/mL, measurable disease with positive immunohistochemical stain for PSA is required. No history of allergy to eggs. No history of or active CNS metastases. Symptomatic spinal or other bony metastasis should be irradiated prior to entry. Bi-dimensionally measurable disease not required. PRIOR/CONCURRENT THERAPY: Biologic Therapy: No concurrent Biologic Therapy. Must fully recover from prior Biologic Therapy. Chemotherapy: At least 4 weeks since prior chemotherapy and fully recovered. No more than 1 prior chemotherapy regimen. No concurrent chemotherapy. Endocrine Therapy: See Disease Characteristics. At least 4 weeks since prior hormonal therapy and fully recovered. No concurrent steroids. Radiotherapy: At least 4 weeks since prior radiation therapy and fully recovered. No prior radiotherapy to more than 50% of nodal groups. No concurrent radiotherapy. Surgery: At least 4 weeks since prior surgery, with surgical scar healed. No prior splenectomy. PATIENT CHARACTERISTICS: Age: Over 18. Performance status: Zubrod (ECOG) 0-2. Hematopoietic: Absolute granulocyte count greater than 2,000/mm(3); Platelet count greater than 100,000/mm(3); Hemoglobin greater than 8.0 g/dL. Hepatic: Bilirubin less than 1.6 mg/dL; AST and ALT less than 4 times normal. Renal: Creatinine less than 1.6 mg/dL. Immunologic: Prior vaccinia (for smallpox immunization) required, with proof of vaccination as follows: Detectable anti-vaccinia antibodies, Physician certification of prior vaccination, Patient recollection or appropriate vaccination-site scar sufficient in patients over age 25, Delayed-type hypersensitivity skin testing (to mumps, Candida, and Trichophyton antigens) normal Quantitative immunoglobulins normal. No evidence of immunocompromise, i.e.: No HIV antibody; No eczema or atopic dermatitis; No autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; No systemic lupus erythematosus, Sjogren syndrome, or scleroderma; No myasthenia gravis; No Goodpasture syndrome; No Addison's disease, Hashimoto's thyroiditis, or active Graves' disease; No other autoimmune disease or diagnosis of altered immune function. OTHER: No active case or history of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition. No active infection requiring antibiotics (including chronic suppressive therapy). At least 3 days since antibiotic therapy. No history of seizures, encephalitis, or multiple sclerosis. No other serious intercurrent illness. Able to avoid close contact with the following individuals for at least 2 weeks after vaccination (i.e., no such individuals as household members and no care-giving responsibilities for such individuals): Children under age 3, Pregnant women, Individuals with eczema or skin conditions defined above, Leukemia or lymphoma patients, HIV-positive individuals, Patients receiving immunosuppressive therapy, Any other immunosuppressed individuals. No prior malignancy unless curatively treated and patient has been in remission for at least 2 years (excluding squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix). Able and willing to travel to the NIH, NCI-NMOB, or the Lombardi Cancer Center at Georgetown University for treatment and follow-up.
Total Enrollment: 75
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 940118; 94-C-0118
Study Start Date: March 25, 1994
Record last reviewed: March 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001382
Other Prostatic Neoplasms Studies:
1. Safety and Efficacy of Atrasentan in Men with Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
2. Protein Measures of Outcome of Radiation Therapy for Prostate Cancer
3. Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.
4. Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer
5. Sequential Vaccinations in Prostate Cancer Patients
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A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate
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