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Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PSA prostate cancer vaccine
recombinant interleukin-12
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the prostate HLA-A2 positive Progressive measurable systemic disease PSA at least 5 ng/mL with 2 consecutive rising PSA levels at least 1 week apart and no measurable disease OR Objective evidence of disease progression by a 20% increase in the sum of longest diameter of all target lesions or evidence of new lesions by CT or bone scan regardless of PSA status Lesions must be at least 1 cm to be considered measurable Progressive systemic disease after discontinuation of anti-androgen therapy Previously treated with orchiectomy (testosterone less than 50 ng/mL) OR luteinizing hormone-releasing hormone (LHRH) analogue therapy with or without anti-androgens If on LHRH analogue therapy, must continue therapy during study Brain metastases allowed if previously treated, clinically stable, and weaned from prior corticosteroids PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Hemoglobin greater than 9 g/dL Platelet count greater than 100,000/mm^3 No active gastrointestinal bleeding Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGPT normal Hepatitis B surface antigen negative Renal: Creatinine less than 1.5 times ULN Calcium less than 11 mg/dL Cardiovascular: No significant cardiovascular disease No cardiac arrhythmia requiring therapy Other: Fertile patients must use effective barrier contraception No intrinsic immunosuppression HIV negative No serious concurrent infection No psychiatric illness that would preclude study compliance No clinically significant autoimmune disease No uncontrolled peptic ulcer disease No history of inflammatory bowel disease PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics At least 4 weeks since prior flutamide At least 6 weeks since prior bicalutamide or nilutamide No concurrent systemic corticosteroids except physiologic replacement doses Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent immunosuppressive drugs (e.g., cyclosporine)

Sites / Locations

  • University of Chicago Cancer Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PSMA peptide vaccine

Arm Description

Immunization with PSMA peptide vaccine followed by injection of Interleukin-12 (IL-12) on Day 1 of a 21-day cycle. Additional injections of IL-12 given on Days 3 and 5 of each cycle.

Outcomes

Primary Outcome Measures

Disease response

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
March 6, 2014
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00015977
Brief Title
Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Vaccines made from a patient's white blood cells may make the body build an immune response to kill cancer cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-12 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy combined with interleukin-12 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES: Determine whether immunization with prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells and interleukin-12 can promote specific T-cell priming in patients with metastatic hormone-refractory prostate cancer. Determine the clinical response in patients treated with this regimen. OUTLINE: Patients receive prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells subcutaneously (SC) on day 1 and interleukin-12 SC on days 1, 3, and 5. Treatment repeats every 21 days for 3-9 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 37 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSMA peptide vaccine
Arm Type
Experimental
Arm Description
Immunization with PSMA peptide vaccine followed by injection of Interleukin-12 (IL-12) on Day 1 of a 21-day cycle. Additional injections of IL-12 given on Days 3 and 5 of each cycle.
Intervention Type
Biological
Intervention Name(s)
PSA prostate cancer vaccine
Intervention Type
Biological
Intervention Name(s)
recombinant interleukin-12
Other Intervention Name(s)
IL-12, rhIL-12
Primary Outcome Measure Information:
Title
Disease response
Time Frame
63 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the prostate HLA-A2 positive Progressive measurable systemic disease PSA at least 5 ng/mL with 2 consecutive rising PSA levels at least 1 week apart and no measurable disease OR Objective evidence of disease progression by a 20% increase in the sum of longest diameter of all target lesions or evidence of new lesions by CT or bone scan regardless of PSA status Lesions must be at least 1 cm to be considered measurable Progressive systemic disease after discontinuation of anti-androgen therapy Previously treated with orchiectomy (testosterone less than 50 ng/mL) OR luteinizing hormone-releasing hormone (LHRH) analogue therapy with or without anti-androgens If on LHRH analogue therapy, must continue therapy during study Brain metastases allowed if previously treated, clinically stable, and weaned from prior corticosteroids PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Hemoglobin greater than 9 g/dL Platelet count greater than 100,000/mm^3 No active gastrointestinal bleeding Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGPT normal Hepatitis B surface antigen negative Renal: Creatinine less than 1.5 times ULN Calcium less than 11 mg/dL Cardiovascular: No significant cardiovascular disease No cardiac arrhythmia requiring therapy Other: Fertile patients must use effective barrier contraception No intrinsic immunosuppression HIV negative No serious concurrent infection No psychiatric illness that would preclude study compliance No clinically significant autoimmune disease No uncontrolled peptic ulcer disease No history of inflammatory bowel disease PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics At least 4 weeks since prior flutamide At least 6 weeks since prior bicalutamide or nilutamide No concurrent systemic corticosteroids except physiologic replacement doses Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent immunosuppressive drugs (e.g., cyclosporine)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F. Gajewski, MD, PhD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

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