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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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:
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
- First posted7 May 2003 (estimated)
- Study startDec 2001
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric J. Small, MD, Study chair, University of California, San Francisco
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00027599
- Acronym / sponsor ID
- NCI-2012-02427
- Conditions
- Prostate Cancer
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2001
- Primary completion
- Jul 2007 (actual)
- First posted
- 7 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | 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 transplantationAutologous 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab | Biological | Arm I |
| prostatic acid phosphatase-sargramostim fusion protein | Biological | Arm I |
| sipuleucel-T | Biological | Arm I |
| therapeutic autologous dendritic cells | Biological | Arm I |
| in vitro-treated peripheral blood stem cell transplantation | Procedure or surgery | Arm I |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J. Small, MD study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
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.