A Phase 2 Study Of Prostate Specific Antigen-3 (PSA-3) (NSC # 694155) With Montanide (NSC #675756) Vaccination In Patients With Prostate Cancer Recurrent
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase 2 Study Of Prostate Specific Antigen-3 (PSA-3) (NSC # 694155) With Montanide (NSC #675756) Vaccination In Patients With Prostate Cancer Recurrent
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Nancy A. Dawson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Maryland Greenebaum Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000069181
NCT ID:
NCT00030602
Start Date:
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- recurrent prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|
