Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy - Full Text View

Sponsor:	Dendreon
Information provided by:	Dendreon
ClinicalTrials.gov Identifier:	NCT00005947

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Biological: sipuleucel-T Biological: Placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Provenge Sipuleucel-T

U.S. FDA Resources

Further study details as provided by Dendreon:

Primary Outcome Measures:

Time to Objective Disease Progression [ Time Frame: 36 months from randomization ] [ Designated as safety issue: Yes ]
The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).

Secondary Outcome Measures:

Overall Survival [ Time Frame: From randomization to 36 months ] [ Designated as safety issue: Yes ]
Overall Survival

Enrollment:	127
Study Start Date:	November 1999
Study Completion Date:	September 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: sipuleucel-T	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. Other Name: APC8015, Provenge
Placebo Comparator: Placebo	Biological: 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.

Detailed 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.

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005947

Show 34 Study Locations

Sponsors and Collaborators

Dendreon

Investigators

Study Chair:

Eric J. Small, MD

University of California, San Francisco

More Information

Additional Information:

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

Publications:

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 refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94.

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.

Responsible Party:	Elizabeth Smith, Dendreon Corporation
ClinicalTrials.gov Identifier:	NCT00005947 History of Changes
Other Study ID Numbers:	D9901 CDR0000067868, DEN-D9901, NCI-G00-1789
Study First Received:	July 5, 2000
Results First Received:	May 28, 2010
Last Updated:	October 8, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dendreon:

adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012