- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00016146
Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer
Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates: A Dose-Escalating Trial Studying The Immunogenicity And Safety Of The Immunological Adjuvant GPI-0100
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
immune function
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Susan Slovin, MD, PhD, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-062
- P30CA008748 (U.S. NIH Grant/Contract)
- MSKCC-99062
- NCI-G01-1941
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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