Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to Objective Disease Progression

Outcome Description:

The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).

Outcome Time Frame:

36 months from randomization

Safety Issue:

Yes

Principal Investigator

Eric J. Small, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

D9901 CDR0000067868

NCT ID:

NCT00005947

Start Date:

November 1999

Completion Date:

September 2004

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Rochester Cancer CenterRochester, New York  14642
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Loma Linda University Medical CenterLoma Linda, California  92354
New York Medical CollegeValhalla, New York  10595
St. Barnabas Medical CenterLivingston, New Jersey  07039
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Albany Regional Cancer CenterAlbany, New York  12208
Hackensack University Medical CenterHackensack, New Jersey  07601
Sidney Kimmel Cancer CenterSan Diego, California  92121
Eisenhower Medical CenterRancho Mirage, California  92270
Earle A. Chiles Research Institute at Providence Portland Medical CenterPortland, Oregon  97213-2967
St. Vincents Comprehensive Cancer CenterNew York, New York  10011
North Penn HospitalLansdale, Pennsylvania  19446-1200
Seattle Cancer Care AllianceSeattle, Washington  98109
Cancer and Blood Institute of the DesertRancho Mirage, California  92270
St. Luke's-Roosevelt HospitalNew York, New York  10019
Saint Mary Regional Cancer CenterLanghorne, Pennsylvania  19047
Hematology/Oncology Associates of NE Pennsylvania, P.C.Scranton, Pennsylvania  18510
Office of Glenn TismanWhittier, California  90601
Office of Barry S. BermanOrlando, Florida  32806
Center for Medical OncologyGarden City, New York  11530
AKSM Clinical Research CorporationColumbus, Ohio  43214
Abington Hematology Oncology Associates, IncorporatedAbington, Pennsylvania  19001
Bryn Mawr UrologyBryn Mawr, Pennsylvania  19010
Office of Guy Bernstein, M.D.Bryn Mawr, Pennsylvania  19010
American Oncology ResourcesDallas, Texas  75246
Devine Tidewater UrologyNorfolk, Virginia  23507
Cancer Care NorthwestSpokane, Washington  99202
Hematology Oncology Northwest, P.C.Tacoma, Washington  98405