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Prostate CancerPhase 2NCT00027599

APC8015 and Bevacizumab in Treating Patients With Prostate Cancer

A Phase 2 study testing bevacizumab, prostatic acid phosphatase-sargramostim fusion protein and sipuleucel-T in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bevacizumab, prostatic acid phosphatase-sargramostim fusion protein and sipuleucel-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Dec 2001to Jul 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: 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.

Read the detailed description

OBJECTIVES:

  1. 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.

Conditions
Prostate Cancer
Being tested
bevacizumab, prostatic acid phosphatase-sargramostim fusion protein, sipuleucel-T, therapeutic autologous dendritic cells, in vitro-treated peripheral blood stem cell transplantation
Keywords
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
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabBiological

  • prostatic acid phosphatase-sargramostim fusion proteinBiological

  • sipuleucel-TBiological

  • therapeutic autologous dendritic cellsBiological

  • in vitro-treated peripheral blood stem cell transplantationProcedure or surgery

Study groups in NCT00027599
Study groupRoleWhat they receive
Arm IExperimentalAutologous 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.
Receives: Biological: bevacizumab; Biological: prostatic acid phosphatase-sargramostim fusion protein; Biological: sipuleucel-T; Biological: therapeutic autologous dendritic cells; Procedure: in vitro-treated peripheral blood stem cell transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2003 (estimated)
  2. Study startDec 2001
  3. Primary completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00027599
Sponsor's protocol ID
NCI-2012-02427
Other IDs
UCSF-0155-01, NCI-2617, UCSF-01554, CDR0000069047
Status last verified
Dec 2003
First submitted
7 Dec 2001
Last updated
11 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, prostatic acid phosphatase-sargramostim fusion protein and sipuleucel-T in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.

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