COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030602
Recruitment Status : Completed
First Posted : February 19, 2004
Last Update Posted : November 5, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Maryland, Baltimore

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: PSA prostate cancer vaccine Biological: incomplete Freund's adjuvant Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Of Prostate Specific Antigen-3 (PSA-3) (NSC # 694155) With Montanide (NSC #675756) Vaccination In Patients With Prostate Cancer Recurrent
Actual Study Start Date : January 2000
Actual Primary Completion Date : December 2001
Actual Study Completion Date : December 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030602

Sponsors and Collaborators
University of Maryland, Baltimore
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Nancy A. Dawson, MD University of Maryland Greenebaum Cancer Center

Layout table for additonal information
Responsible Party: University of Maryland, Baltimore Identifier: NCT00030602    
Other Study ID Numbers: MSGCC-0074
CDR0000069181 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: February 19, 2004    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: October 2019
Keywords provided by University of Maryland, Baltimore:
adenocarcinoma of the prostate
recurrent prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic