Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer

NCT01338012 | Terminated Phase 2 Results

• 1 other identifier: P10-1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 4

Brief Summary

Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

Conditions

Prostate Cancer

Keywords

metastatic castrate resistant prostate cancer; prostate cancer; prostate; immune therapy; immunotherapy; vaccine; dendritic cells; antigen-presenting cells; antigen presenting cells; cancer vaccine; prostatic adenocarcinoma; Sipuleucel-T; castration resistant prostate cancer (CRPC); booster; retreatment; immune memory; immune response

Outcome Measures

Primary Outcomes (1)

• Number of Study Participants Enrolled and Treated Prior to Study Termination

  Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.

  Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015

Study Arms (1)

sipuleucel-T

EXPERIMENTAL

Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.

Biological: sipuleucel-T

Interventions

sipuleucel-T BIOLOGICAL

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

Also known as: PROVENGE, APC8015

sipuleucel-T

Eligibility Criteria

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

You may qualify if:

• Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T
• Radiologic evidence of metastasis
• Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease
• Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration
• Adequate hematologic function

You may not qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status \> 2
• Treatment with chemotherapy within 3 months prior to registration
• Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration
• Treatment with commercial sipuleucel-T (Provenge®)
• Current or imminent pathologic long-bone fracture or spinal cord compression
• Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
• A requirement for systemic immunosuppressive therapy for any reason
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF
• Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration
• Any surgery requiring general anesthetic within 28 days prior to registration

Sponsors & Collaborators

• Dendreon: lead

Study Sites (4)

Orange County Urology Associates

Laguna Hills, California, 92653, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Virginia Mason Hospital

Seattle, Washington, 98101, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sipuleucel-T

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study was terminated early due to administrative reasons. Only 8 subjects were enrolled and treated. Given the small number of patients enrolled, analyses do not provide reliable results.

Results Point of Contact

• Title: Shabnam Vaziri
• Organization: Dendreon

svaziri@dendreon.com

206-455-2323

Study Officials

• Robert Israel, MD

  Valeant Pharmaceuticals North America LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: April 19, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 5, 2017
• Results First Posted: June 5, 2017

Record last verified: 2017-06

Locations

US (4)