Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer

NCT ID: NCT00016146

Last Updated: 2013-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2009-03-31

Brief Summary

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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vaccine

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.

Group Type: EXPERIMENTAL

GPI-0100

Intervention Type: BIOLOGICAL

MUC-2-Globo H-KLH conjugate vaccine

Intervention Type: BIOLOGICAL

Interventions

GPI-0100

Intervention Type: BIOLOGICAL

MUC-2-Globo H-KLH conjugate vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Slovin, MD, PhD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-99062

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1941

Identifier Type: -

Identifier Source: secondary_id

99-062

Identifier Type: -

Identifier Source: org_study_id