Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: GPI-0100 Biological: MUC-2-Globo H-KLH conjugate vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- immune function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | July 2000 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Biological: GPI-0100 Biological: MUC-2-Globo H-KLH conjugate vaccine |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Susan Slovin, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00016146 History of Changes |
| Other Study ID Numbers: | 99-062, P30CA008748, MSKCC-99062, NCI-G01-1941 |
| Study First Received: | May 6, 2001 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013