Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

NCT00030602 | Completed Phase 2

• 3 other identifiers: MSGCC-0074CDR0000069181NCI-2812
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Interventions

PSA prostate cancer vaccine BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

incomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nancy A. Dawson, MD

  University of Maryland Greenebaum Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: February 19, 2004
• Study Start: January 1, 2000
• Primary Completion: December 1, 2001
• Study Completion: December 1, 2001
• Last Updated: November 5, 2019

Record last verified: 2019-10