Expired Study
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New York, New York 10021


Purpose:

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 II trial to study the effectiveness of combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer.


Study summary:

OBJECTIVES: - Determine the safety of a multivalent conjugate vaccine comprising Globo H, GM2, Lewis-y, MUC-1-32-mer, TF(c), and Tn(c) antigens conjugated to keyhole limpet hemocyanin (KLH) with adjuvant QS21 in patients with biochemically relapsed prostate cancer. - Measure the antibody response against the individual components of the vaccine and correlate the response to subsequent clinical course in patients treated with this vaccine. - Assess post-immunization changes in prostate-specific antigen levels and other objective parameters of the disease in these patients. OUTLINE: Patients receive Globo H, MUC-1-32mer, GM2, Lewis-y, Tn(c), TF(c)-KLH conjugate vaccine with adjuvant QS21 subcutaneously weekly on weeks 1, 2, 3, 7, 19, 31, 43, and 55. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 6 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer - Biochemically progressive disease after primary therapy, including surgery or radiotherapy, with or without neoadjuvant androgen ablation - Log of prostate-specific antigen (PSA) slope greater than 0.15 as determined by at least 3 measurements taken at 2-week intervals within 12 months - Minimal baseline PSA value prior to study: - Post-prostatectomy: 0.1 ng/mL - Post-radiotherapy: 1.0 ng/mL - Intermittent hormonal therapy: 1.0 ng/mL - Patients with prior intermittent hormonal therapy after primary therapy and non-castrate levels of testosterone (greater than 50 ng/mL) are eligible - No radiographic evidence of metastatic disease - Concurrent registration to MSKCC-90040 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-IV) Pulmonary: - No severe debilitating pulmonary disease Other: - No other prior malignancy within the past 5 years except nonmelanoma skin cancer or melanoma in situ - No allergy to seafood - No narcotic-dependent pain - No infection requiring antibiotics - No positive stool guaiac except hemorrhoids or history of documented radiation induced proctitis PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior vaccine therapy except on phase I monovalent trial at Memorial Sloan Kettering Cancer Center Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - See Disease Characteristics 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


NCT ID:

NCT00016120


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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