NCT00027599

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

February 11, 2013

Status Verified

December 1, 2003

Enrollment Period

5.6 years

First QC Date

December 7, 2001

Last Update Submit

February 8, 2013

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancer

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Biological: bevacizumabBiological: prostatic acid phosphatase-sargramostim fusion proteinBiological: sipuleucel-TBiological: therapeutic autologous dendritic cellsProcedure: in vitro-treated peripheral blood stem cell transplantation

Interventions

bevacizumabBIOLOGICAL
Arm I
prostatic acid phosphatase-sargramostim fusion proteinBIOLOGICAL
Arm I
sipuleucel-TBIOLOGICAL
Arm I
therapeutic autologous dendritic cellsBIOLOGICAL
Arm I
in vitro-treated peripheral blood stem cell transplantationPROCEDURE
Arm I

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Bevacizumabsipuleucel-T

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Eric J. Small, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 7, 2001

First Posted

May 7, 2003

Study Start

December 1, 2001

Primary Completion

July 1, 2007

Last Updated

February 11, 2013

Record last verified: 2003-12

Locations

US(1)