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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 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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:

NCI-2012-02427

NCT ID:

NCT00027599

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

UCSF Comprehensive Cancer CenterSan Francisco, California  94115