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Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer Clinical research trials and Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer. Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer  Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer
Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer
For Condition: recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness in combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer.
Details: OBJECTIVES: - Determine the optimal (in terms of antibody response) and safe dose range of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 in patients with biochemically relapsed prostate cancer. - Assess post-immunization changes in prostate-specific antigen levels and other objective parameters of disease in these patients. OUTLINE: This is a dose-escalation study of GPI-0100. Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 subcutaneously weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity or disease progression. Cohorts of 5 patients receive escalating doses of GPI-0100 until the optimal dose, based on antibody response, is reached. Patients are followed every 3 months. PROJECTED ACCRUAL: A maximum of 25 patients 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 prostate cancer - Biochemically progressive disease after primary surgery or radiotherapy with or without neoadjuvant androgen ablation - Greater than 50% increase in PSA level above baseline value of 1.0 ng/mL post-prostatectomy or 2.0 ng/mL post-radiotherapy, based on 3 successive determinations taken at 2-week intervals - Patients with prior intermittent hormonal therapy and non-castrate levels of testosterone are eligible - Evaluable disease - No radiographic evidence of metastasis - No active CNS or epidural tumor - No soft tissue and/or bone disease - No androgen-independence with no evidence of radiographic disease - May not be symptomatic or anticipated to develop symptoms within 6 months of study entry - Concurrent registration to protocol MSKCC-90-040 required PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - At least 6 months Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL OR - SGOT less than 3 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 40 mL/min Cardiovascular: - No clinically significant cardiac disease (New York Heart Association class III or IV) Pulmonary: - No severe debilitating pulmonary disease Other: - No other prior malignancy within the past 5 years except nonmelanoma skin cancer - No positive stool guaiac except hemorrhoids or history of documented radiation-induced proctitis - No narcotic-dependent pain - No infection requiring antibiotics - No requirement for immunosuppressive therapy - No allergy to seafood PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - See Disease Characteristics - At least 2 weeks since change in hormonal therapy (except to maintain castrate levels of testosterone), including prednisone or dexamethasone - At least 8 weeks since prior suramin and/or documented plasma concentration - of suramin is less than 50 micrograms/mL (replacement hydrocortisone allowed) Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy to only measurable lesion Surgery: - See Disease Characteristics - No concurrent surgery of only measurable lesion Other: - Recovered from prior therapy - No other concurrent oncolytic agents - No concurrent immunosuppressive therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanSlovin, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068598; MSKCC-99062,NCI-G01-1941
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016146
Other Recurrent Prostate Cancer Studies:
1. Perifosine in Treating Patients With Recurrent Prostate Cancer
2. Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
3. Paclitaxel, Estramustine, and Thalidomide in Treating Patients With Progressive Metastatic Androgen-Independent Prostate Cancer
4. Biological Therapy in Treating Patients With Prostate Cancer
5. Monoclonal Antibody Therapy Plus Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer
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