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

Prostate Cancer Clinical Trial

Official title:

Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00015977
• Other study ID #: 9845
• Secondary ID: UCCRC-9845NCI-11
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2001
• Last updated: March 6, 2014
• Start date: November 2001
• Est. completion date: January 2005

Study information

• Verified date: March 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2005
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• PSA prostate cancer vaccine

• recombinant interleukin-12

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease response		63 days	No