Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

October 31, 2019 updated by: University of Maryland, Baltimore

A Phase 2 Study Of Prostate Specific Antigen-3 (PSA-3) (NSC # 694155) With Montanide (NSC #675756) Vaccination In Patients With Prostate Cancer Recurrent

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the effect of PSA-3 peptide vaccine emulsified in Montanide ISA-51 on PSA levels in patients with recurrent prostate cancer. II. Determine the toxicity of this regimen in these patients. III. Determine whether the T lymphocyte immune response to PSA-3 and HLA-A2 antigen-presenting cells that endogenously produce PSA is increased in patients treated with this regimen. IV. Determine the duration of the PSA and/or immune responses in patients treated with this regimen. V. Correlate immune and PSA responses in patients treated with this regimen. VI. Determine the efficacy of a second (boost) vaccination with this regimen in patients with a PSA or immune response.

OUTLINE: This is a multicenter study. Patients receive PSA-3 peptide vaccine emulsified in Montanide ISA-51 subcutaneously in 2 sites on days 1, 8, 15, and 22 in the absence of unacceptable toxicity. Patients who show an immune or prostate specific antigen (PSA) response are followed until disease progression, defined as a diminution or disappearance of an immune response or 2 consecutive increases in PSA over the nadir. Patients are eligible for a second series of injections at the time of progression.

PROJECTED ACCRUAL: A total of 14-44 patients will be accrued for this study within 12-18 months.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate Previously treated with radical prostatectomy at least 3 months ago HLA-A2 positive PSA greater than 0.5 ng/mL and rising At least 0.3 ng/mL greater than post-prostatectomy nadir Confirmed by at least 2 additional PSA levels at least 2 weeks apart No bone metastases by bone scan within past 3 months No clinical evidence of local disease recurrence (no palpable mass or induration in prostatic fossa)

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 OR Karnofsky 70-100% Life expectancy: More than 1 year Hematopoietic: WBC at least 3,000/mm3 Hepatic: Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Fertile patients must use effective contraception HIV negative No clinical immune dysfunction illness (e.g., rheumatoid arthritis) No ongoing or active infection No other concurrent uncontrolled illness that would preclude study No concurrent psychiatric illness or social situation that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Neoadjuvant hormonal therapy prior to prostatectomy allowed No concurrent hormonal therapy for recurrent prostate cancer Radiotherapy: No prior radiotherapy to the prostate No prior radiotherapy to the pelvis Surgery: See Disease Characteristics Other: No other concurrent investigational agents No concurrent commercial agents intended to treat the malignancy No concurrent immunosuppressive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Nancy A. Dawson, MD, University of Maryland Greenebaum Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

December 1, 2001

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

February 18, 2004

First Posted (Estimate)

February 19, 2004

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSGCC-0074
  • CDR0000069181 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-2812

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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