Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer

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.

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