Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease response

Outcome Time Frame:

63 days

Safety Issue:

No

Principal Investigator

Thomas F. Gajewski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

9845

NCT ID:

NCT00015977

Start Date:

November 2001

Completion Date:

January 2005

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637