APC8015 and Bevacizumab in Treating Patients With Prostate Cancer

February 8, 2013 updated by: National Cancer Institute (NCI)

A Phase II Study Of Prostatic Acid Phosphatase-Pulsed Dendritic Cells (Provenge) In Combination With Bevacizumab In Patients With Serologic Progression Of Prostate Cancer After Definitive Local Therapy

Phase II trial to study the effectiveness of APC8015 combined with bevacizumab in treating patients who have undergone radiation therapy and/or surgery and who have progressive prostate cancer. Biological therapies such as APC8015 use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as bevacizumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with biological therapy may kill more cancer cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Determine the efficacy of APC8015 (Provenge) and bevacizumab, in terms of decline in prostate-specific antigen (PSA) value and effect on PSA doubling time, in patients with progressive prostate cancer.

II. Determine any immune response in patients treated with this regimen. III. Determine the safety of this regimen in these patients.

OUTLINE:

Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every month.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Any T, any N, M0

  • Received prior therapy comprising one of the following regimens for primary prostate cancer:

    • External beam radiotherapy
    • Brachytherapy with or without pelvic external beam radiotherapy
    • Cryosurgery

    • Radical prostatectomy with or without adjuvant or salvage radiotherapy

      • Adjuvant or salvage radiotherapy after radical prostatectomy is allowed provided the following criteria is met:

        • PSA was never greater than 6.0 ng/mL
        • At least 3 months since androgen deprivation
  • Elevated PSA (0.4-6.0 ng/mL) that has increased on 2 measurements taken at least 2 weeks apart
  • No history of or radiological evidence of current CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases)

PATIENT CHARACTERISTICS:

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 months

Hematopoietic:

  • WBC greater than 2,500/mm^3
  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • No prior bleeding disorder

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 2 times ULN
  • Hepatitis B and C negative

Renal:

  • Creatinine no greater than 2 times ULN
  • BUN no greater than 2 times ULN

Cardiovascular:

  • No clinically significant cardiovascular disease
  • No New York Heart Association grade II-IV heart disease (symptomatic congestive heart failure)
  • No unstable angina pectoris
  • No serious cardiac arrhythmia requiring medication
  • No uncontrolled hypertension
  • No prior myocardial infarction
  • No grade II or greater peripheral vascular disease within the past year
  • No prior deep vein thrombosis

Other:

  • Fertile patients must use effective contraception
  • HIV and HTLV I and II negative
  • No other uncontrolled illness, underlying medical condition, psychiatric illness, or social situation that would preclude study participation
  • No ongoing or active infection
  • No active autoimmune disease requiring treatment
  • No significant traumatic injury within the past 4 weeks
  • No serious nonhealing wound, ulcer, or bone fracture

  • No other "currently active" malignancy except nonmelanoma skin cancer

    • Not "currently active" if considered by physician as having less than 30% risk of relapse after completion of therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy
  • No prior anti-vascular endothelial growth factor therapy

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • No prior hormonal therapy (e.g., luteinizing hormone-releasing hormone [LHRH] agonists or antagonists, antiandrogens, estrogens, megestrol, or PC-SPES) for progressive disease
  • Prior hormonal therapy in adjuvant or neoadjuvant setting as primary therapy allowed if at least 3 months since androgen deprivation
  • No concurrent systemic steroid therapy (inhaled or topical steroids allowed)

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery, including open biopsy or needle biopsy of liver
  • No concurrent major surgery

Other:

  • At least 10 days since prior aspirin
  • At least 10 days since prior oral or parenteral anticoagulants except to maintain patency of pre-existing permanent indwelling IV catheters
  • No concurrent aspirin
  • No concurrent oral or parenteral anticoagulants except to maintain patency of pre-existing permanent indwelling IV catheters
  • No other concurrent experimental or commercial agents or therapies for prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
Procedure: in vitro-treated peripheral blood stem cell transplantation
Biological: bevacizumab
Biological: therapeutic autologous dendritic cells
Biological: sipuleucel-T
Biological: prostatic acid phosphatase-sargramostim fusion protein

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

December 7, 2001

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02427
  • UCSF-0155-01
  • NCI-2617
  • UCSF-01554
  • CDR0000069047 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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