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.

Condition	Treatment or Intervention	Phase
stage II prostate cancer stage III prostate cancer stage I prostate cancer recurrent prostate cancer	Drug: keyhole limpet hemocyanin  Drug: QS21  Drug: QS21/TF(c)-KLH conjugate vaccine  Drug: TF(c)-KLH conjugate vaccine  Drug: Thompson-Friedenreich antigen	Phase I

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Susan Slovin,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000066971; MSKCC-98048; NCI-G99-1510
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003819
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08