Study of APC8015F Immunotherapy in Prostate Cancer Patients Who Participated in Study D9902B and Have Experienced Disease Progression and Disease-Related Pain - Full Text View

Sponsors and Collaborators:	Mayo Clinic Dendreon
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00170066

Purpose

The purpose of this research study is to determine whether APC8015F prepared from frozen cells is safe and effective as treatment for prostate cancer. Researchers believe that APC8015F prepared from 2/3 of participants' previously collected leukapheresis product may stimulate their immune system to attack the prostate cancer cells. Additionally, treatment with fewer cells may result in fewer side effects.

This study is open to participants who were assigned to receive APC-Placebo in the D9902B study, who have experienced worsening disease (progression) and disease-related pain. Participation in this study must begin within six months of having both disease progression and disease-related pain on Protocol D9902B.

Condition	Intervention	Phase
Prostate Cancer	Drug: APC8015F	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Provenge Sipuleucel-T

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label, Single Arm Trial of Immunotherapy With Autologous Antigen Presenting Cells Loaded With PA2024 (APC8015F) for Subjects With Objective Disease Progression and Disease-Related Pain on Protocol D9902 Part B

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Safety analysis [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PSA doubling time [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Overall clinical response [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	92
Study Start Date:	July 2003
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will receive an infusion of APC8015F at Weeks 0, 2, and 4.

Detailed Description:

APC8015F is an autologous cell product prepared from cryopreserved antigen presenting cell (APC) precursors loaded with prostate antigen PA2024. PA2024 is a recombinant fusion protein composed of prostatic acid phosphatase (PAP) linked to granulocyte-macrophage colony stimulating factor (GM-CSF); GM-CSF acts as a targeting molecule that directs the PAP antigen to APCs and promotes antigen uptake and processing. Residual levels of PA2024 are not detectable in the final product. Three leukapheresis procedures were performed during the D9902, Part B Protocol (D9902B), and two thirds of control subjects antigen presenting cell precursors were cryopreserved. In this trial, the cryopreserved APC precursors from one product (two third of the APC precursors originally isolated) will be thawed and loaded with the PA2024 antigen. A dose of APC8015F has a minimum final concentration of 10 million CD54+ cells (the biologically active component of APC8015), which is administered via a single intravenous infusion at Weeks 0, 2 and 4.

The biologic activity of APC8015F is thought to be similar to that of APC8015 [Provenge(R)]. This protocol seeks to explore whether APC8015F prepared from cryopreserved APC precursors obtained from 2/3 of a leukapheresis product is a safe and effective treatment for prostate cancer. Ths amount of APC8015F may stimulate the immune system to attack the prostate cancer cells. Moreover, treatment with fewer cells may result in fewer side effects.

Eligibility

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

Criteria

Eligibility criteria:

Written informed consent obtained prior to the initiation of study procedures.
Confirmation of objective disease progression and disease-related pain while on Protocol D9902B. D9902B subjects who have not met both co-primary endpoint at the time Protocol D9902B is closed and analyzed for these endpoints will also be eligible for unblinding and possible participation in this trial.
Enrollment in the control arm of Protocol D9902B.
ECOG Performance Status of <2.
Life expectancy of at least 24 weeks.
Adequate hematological, renal and liver function as evidenced by the following:
- WBC >= 2,000
- ANC >= 1,000
- Platelet count >= 100,000/µL
- HgB >= 9 gm/dL
- Creatinine <= 2.0
- Total Bilirubin <= 2 x ULN
- AST, ALT <= 2.5 x ULN

Exclusion criteria:

Any antibiotic therapy or infection within 1 week prior to registration, including unexplained fever (temp >100.5 F or 38.1 C).
Initiation or discontinuation of bisphosphonate therapy within 14 days prior to registration. Subjects taking bisphosphonate medication should not have their dosing regimen altered during the trial unless medically warranted.
Treatment with any of the following medications or interventions within 14 days of registration:
- Systemic corticosteroids. Use of inhaled, intranasal and topical steroids is acceptable.
- External beam radiation therapy or surgery.
- PC-SPES or Saw Palmetto.
- Megestrol acetate (Megace[R]) or diethyl stilbesterol (DES).
- Ketoconazole.
- -reductase inhibitors (e.g. finasteride), high dose calcitriol [1,25(OH)2VitD] or any other systemic therapy for prostate cancer.
Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170066

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Dendreon

Investigators

Principal Investigator:

Patrick A. Burch, M.D.

Mayo Clinic

More Information

Responsible Party:	Mayo Clinic ( Patrick Burch, M.D. )
Study ID Numbers:	436-04, PB01
Study First Received:	September 12, 2005
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00170066
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Disease Progression
Urogenital Neoplasms

Pain
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009