Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Biological: MUC-2-Globo H-KLH conjugate vaccine; Biological: GPI-0100

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00016146

MSKCC-99062

P30CA008748 (U.S. NIH Grant/Contract)

NCI-G01-1941

99-062

Details and patient eligibility

About

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

Full description

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.

Enrollment: 34 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

vaccine

Experimental group

Description:

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.

Treatment:

Biological: MUC-2-Globo H-KLH conjugate vaccine

Biological: GPI-0100