Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as QS21 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with QS21 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with QS21 in treating patients who have prostate cancer.

Detailed Description
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OBJECTIVES: Determine the safety of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 in patients with prostate cancer. Determine the antibody response in patients treated with this vaccination therapy. Assess post-immunization changes in PSA levels and other objective parameters of disease (radionuclide bone scan) in patients treated with this vaccination therapy. OUTLINE: Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40 and who have no disease progression may receive a seventh vaccination after week 50. Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic disease progression.

Official Title
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Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: MUC-2-Globo H-KLH conjugate vaccine
* Biological: QS21


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Disease progression after primary surgery (radical prostatectomy) or radiotherapy with or without prior neoadjuvant androgen ablation Minimum of 3 rising PSA values, taken at least 2 weeks apart, with more than a 50% rise in PSA level above the baseline value (1.0 ng/mL post -prostatectomy or 2.0 ng/mL post-radiotherapy) Received prior intermittent hormonal therapy after prior primary therapy Non-castrate levels of testosterone (more than 50 ng/mL) Evaluable disease (by serial changes in PSA) No radiographic evidence of metastatic disease 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 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 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 allergy to seafood (shellfish) No other active malignancy within the past 5 years except nonmelanoma skin cancer No infection requiring antibiotics No narcotic-dependent pain No positive stool guaiac unless associated with hemorrhoids or prior documented radiation-induced proctitis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics See Chemotherapy At least 2 weeks since change in hormonal therapy (e.g., prednisone or dexamethasone) except to maintain castrate levels of testosterone Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent irradiation of only measurable lesion Surgery: See Disease Characteristics No concurrent surgery of only measurable lesion Other: Recovered from prior therapy At least 8 weeks since prior suramin and/or documented plasma concentration of suramin if less than 50 micrograms/mL (replacement hydrocortisone allowed) No other concurrent oncolytic agents No concurrent immunosuppressive therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccine<br>Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40 and who have no disease progression may receive a seventh vaccination after week 50. Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic disease progression. | Biological: MUC-2-Globo H-KLH conjugate vaccine<br> <br> Biological: QS21<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III prostate cancer, recurrent prostate cancer