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Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer



Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer

For Condition: stage 2 prostate cancer,stage 1 prostate cancer,stage 3 prostate cancer,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer.
Details: OBJECTIVES: I. Determine the optimal dose of Thompson-Friedenreich [TF(c)]-keyhole limpet hemocyanin (KLH) conjugate plus adjuvant QS21 that induces an antibody response in patients with prostate cancer. II. Determine the safety of the TF(c)-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21. III. Assess postimmunization changes in prostate specific antigen levels and other objective parameters of disease in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive TF(c)-KLH conjugate with adjuvant QS21 subcutaneously weekly for 3 weeks, then once during weeks 7 and 19. Cohorts of 5 patients each receive escalating doses of TF(c)-KLH vaccine until the optimal dose, based on antibody response, is reached. Patients are followed monthly for 6 months, then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven progressive prostate cancer after primary therapy; Radiographic changes OR PSA at least 1.0 ng/mL and rising after prostatectomy OR PSA at least 2.0 ng/mL and rising after radiotherapy OR PSA rising 50% during intermittent hormonal therapy - No metastatic disease by radiography - No active CNS or epidural tumor - Registered on MSKCC-9040 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered; No concurrent 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 serum concentration of suramin must be less than 50 micrograms/mL (replacement hydrocortisone allowed) - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy and recovered; No concurrent therapy to only measurable lesion - Surgery: See Disease Characteristics; No concurrent surgery --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: At least 6 months - Hematopoietic: WBC at least 3500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3.0 times upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 40 mL/min - Cardiovascular: No New York Heart Association class III/IV cardiac disease - Pulmonary: No severe debilitating pulmonary disease - Other: No other active malignancy within 5 years except nonmelanomatous skin cancer; No infection requiring antibiotics; No narcotic dependent pain; No positive stool guaiac excluding hemorrhoids; No radiation induced proctitis; No allergy to seafood
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:  CDR0000066971;  MSKCC-98048,NCI-G99-1510
Study Start Date: June 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003819

Other Stage 2 Prostate Cancer Studies:
1. Isoflavones in Preventing Further Development of Cancer in Patients With Stage I or Stage II Prostate Cancer

2. Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer

3. Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer

4. Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

5. Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

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