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Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GPI-0100
MUC-2-Globo H-KLH conjugate vaccine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vaccine

Arm 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.

Outcomes

Primary Outcome Measures

safety

Secondary Outcome Measures

immune function

Full Information

First Posted
May 6, 2001
Last Updated
March 18, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00016146
Brief Title
Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vaccine
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
GPI-0100
Intervention Type
Biological
Intervention Name(s)
MUC-2-Globo H-KLH conjugate vaccine
Primary Outcome Measure Information:
Title
safety
Time Frame
2 years
Secondary Outcome Measure Information:
Title
immune function
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Slovin, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer

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