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Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030602
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: PSA prostate cancer vaccine
Drug: incomplete Freund's adjuvant
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Freund's adjuvant Montanide ISA 51
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

Further study details as provided by National Cancer Institute (NCI):

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030602

Sponsors and Collaborators
University of Maryland Greenebaum Cancer Center
Investigators
Study Chair: Nancy A. Dawson, MD University of Maryland Greenebaum Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069181, MSGCC-0074, NCI-2812
Study First Received: February 14, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00030602  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Freund's Adjuvant
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009