Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Prostate Cancer Clinical Trial

Official title:

A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005947
• Other study ID #: D9901 CDR0000067868
• Secondary ID: DEN-D9901NCI-G00
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2000
• Last updated: October 8, 2010
• Start date: November 1999
• Est. completion date: September 2004

Study information

• Verified date: October 2010
• Source: Dendreon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer.

Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Description:

Objectives:

I. Compare the time to progression, time to development of disease-related pain, and incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus control infusion. II. Compare response rate and duration of response in these patients.

Outline: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Autologous dendritic cell precursors (ADCP) are harvested on weeks 0, 2, and 4. Patients receive APC8015 comprised of ADCP activated with prostatic acid phosphatase-sargramostim (GM-CSF) fusion protein IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Arm II: ADCP are harvested as in arm I. Patients receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Pain is assessed weekly for up to 3 years or until 4 weeks after objective disease progression. Patients are followed monthly for up to 3 years or until disease progression. At the time of disease progression, patients treated on arm II may receive treatment on Protocol D9903.

Projected Accrual: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria include:

• Metastatic disease as evidenced by soft tissue and/or bony metastases.

• Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA.

• Tumor progression after hormonal therapy.

• Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for treatment of prostate cancer. Castration levels of testosterone (< 50 ng/dL) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate.

• A subject is eligible if he initially responded to antiandrogen withdrawal (> 25% decrease in PSA) but at the time of registration demonstrated tumor progression. A subject is eligible if he failed to respond to antiandrogen withdrawal.

• Subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain.

• ECOG Performance Status of 0 or 1.

• Life expectancy of at least 16 weeks.

• Adequate hematologic, renal, and liver function.

Exclusion Criteria include:

• Visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites).

• Metastatic disease expected to be in need of radiation therapy within 4 months.

• Concurrent therapy with experimental agents.

• Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.

Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• sipuleucel-T
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
• Placebo
Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

Locations

Country	Name	City	State
United States	Abington Hematology Oncology Associates, Incorporated	Abington	Pennsylvania
United States	Albany Regional Cancer Center	Albany	New York
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	Bryn Mawr Urology	Bryn Mawr	Pennsylvania
United States	Office of Guy Bernstein, M.D.	Bryn Mawr	Pennsylvania
United States	AKSM Clinical Research Corporation	Columbus	Ohio
United States	American Oncology Resources	Dallas	Texas
United States	Cancer Center and Beckman Research Institute, City of Hope	Duarte	California
United States	Center for Medical Oncology	Garden City	New York
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Saint Mary Regional Cancer Center	Langhorne	Pennsylvania
United States	North Penn Hospital	Lansdale	Pennsylvania
United States	St. Barnabas Medical Center	Livingston	New Jersey
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	New York Presbyterian Hospital - Cornell Campus	New York	New York
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	St. Luke's-Roosevelt Hospital	New York	New York
United States	St. Vincents Comprehensive Cancer Center	New York	New York
United States	Devine Tidewater Urology	Norfolk	Virginia
United States	Office of Barry S. Berman	Orlando	Florida
United States	Earle A. Chiles Research Institute at Providence Portland Medical Center	Portland	Oregon
United States	Cancer and Blood Institute of the Desert	Rancho Mirage	California
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	University of Rochester Cancer Center	Rochester	New York
United States	Sidney Kimmel Cancer Center	San Diego	California
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	Hematology/Oncology Associates of NE Pennsylvania, P.C.	Scranton	Pennsylvania
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Cancer Care Northwest	Spokane	Washington
United States	Hematology Oncology Northwest, P.C.	Tacoma	Washington
United States	New York Medical College	Valhalla	New York
United States	Office of Glenn Tisman	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Dendreon

Country where clinical trial is conducted

United States, 

References & Publications (2)

Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer. 2009 Aug 15;115(16):3670-9. doi: 10.1002/cncr.24429. — View Citation

Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refracto — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Objective Disease Progression	The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).	36 months from randomization	Yes
Secondary	Overall Survival	Overall Survival	From randomization to 36 months	Yes