Prostate CancerPhase 3NCT00043212
Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.
A Phase 3 study testing Dendritic cell immunotherapy in people with Prostate Cancer, run by Northwest Biotherapeutics at 16 sites in United States.
Trial summary
The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Dendritic cell immunotherapy
- How many people
- 0 participants
- Where
- 16 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hormone refractory prostate cancer (HRPC) \– progressive disease despite androgen deprivation and serum testosterone <50ng/dL; progression defined as either:
- Rising PSA over 6 months with at least a 50% increase between the 1st and 3rd measurement, and the 3rd measurement >2.0 ng/ml; or
- Progression of metastatic lesion on bone scan, or
- Progression of lymph node metastasis by CT scan.
- Zubrod or ECOG performance status of 0-1.
- Three or fewer bone metastases on a bone scan with minimal symptoms.
- No lymph node lesions greater than 3.0 cm at longest diameter.
- Adequate hematological, hepatic and renal function.
Who cannot join
- History of other active malignancy.
- Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months.
- Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment.
- Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness.
- Prior splenectomy.
- History of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines or any of the antigens included in the skin test.
Show all 10Show fewer
- History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke.
- History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV.
- Impending untreated spinal cord compression or urinary outlet obstruction.
- Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Albany Regional Cancer Center
Albany, New York
Carolinas HealthCare System
Charlotte, North Carolina
Cleveland Clinic Foundation
Cleveland, Ohio
Mary Crowley Medical Research Center
Dallas, Texas
Clinical Research Solutions
Las Vegas, Nevada
University of California, Los Angeles
Los Angeles, California
St. Luke's Medical Center
Milwaukee, Wisconsin
Louisiana State University
New Orleans, Louisiana
Cancer Centers of Florida, P.A.
Orlando, Florida
St. Francis Medical Center
Peoria, Illinois
University of Utah
Salt Lake City, Utah
University of California, San Diego Medical Center
San Diego, California
Cancer Care Northwest
Spokane, Washington
Highlands Oncology Group
Springdale, Arkansas
Tyler Cancer Center
Tyler, Texas
Walter Reed Army Medical Center
Washington D.C., District of Columbia
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating DCVax(tm)-Prostate, Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer
The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.
Read the detailed description
Patients with hormone refractory prostate cancer are eligible if they have a rising PSA or three or fewer metastatic lesions. The experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize a "flag" on prostate cancer cells. This may help the immune system destroy prostate cancer cells. Side effects reported from the Phase I/II trial include skin reactions of redness, pain \& swelling at the injection site, and short-lived headache, fever \& fatigue. Full details are available in the informed consent.
- Conditions
- Prostate Cancer
- Being tested
- Dendritic cell immunotherapy
- Keywords
- prostate cancer, oncology, urology, hormone refractory prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic cell immunotherapyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2002 (estimated)
Why it stopped: Redirection of company goals
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwest Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043212
- Sponsor's protocol ID
- DC3-HRPC, October 2001
- Status last verified
- Apr 2013
- First submitted
- 6 Aug 2002
- Last updated
- 1 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating DCVax(tm)-Prostate, Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00043212
- Acronym / sponsor ID
- DC3-HRPC, October 2001
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, oncology, urology, hormone refractory prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Redirection of company goals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwest BiotherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 8 Aug 2002 (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.
The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.
Detailed description
Patients with hormone refractory prostate cancer are eligible if they have a rising PSA or three or fewer metastatic lesions. The experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize a "flag" on prostate cancer cells. This may help the immune system destroy prostate cancer cells. Side effects reported from the Phase I/II trial include skin reactions of redness, pain \& swelling at the injection site, and short-lived headache, fever \& fatigue. Full details are available in the informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hormone refractory prostate cancer (HRPC) \– progressive disease despite androgen deprivation and serum testosterone <50ng/dL; progression defined as either:
- Zubrod or ECOG performance status of 0-1.
- Three or fewer bone metastases on a bone scan with minimal symptoms.
- No lymph node lesions greater than 3.0 cm at longest diameter.
- Adequate hematological, hepatic and renal function.
Key exclusion criteria (10 listed)
- History of other active malignancy.
- Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months.
- Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment.
- Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness.
- Prior splenectomy.
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 |
|---|---|---|
| Dendritic cell immunotherapy | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
- Northwest Biotherapeutics, Inc.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dendritic cell immunotherapy in people with Prostate Cancer, run by Northwest Biotherapeutics at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 1 May 2013.