Prostate CancerPhase 1/2NCT00140348
Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine
A Phase 1/2 study testing Immunotherapy allogeneic GM-CSF secreting cellular vaccine in people with Prostate Cancer, run by Cell Genesys at 12 sites in United States.
Trial summary
The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose. 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?
- Immunotherapy allogeneic GM-CSF secreting cellular vaccine
- Type of treatment
- Vaccines
- How many people
- 80 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2001to Apr 2005
- Phase
- Phase 1/2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of adenocarcinoma of the prostate
- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
- Detectable metastases
- ECOG performance status of 0 or 1
Who cannot join
- Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- Significant cancer related pain
- Prior gene therapy, chemotherapy, or immunotherapy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
South Florida Medical Research
Aventura, Florida, 33180
Northeast Indiana Research
Fort Wayne, Indiana, 46825
South Orange County Medical Research Center
Laguna Woods, California, 92637
Fox Chase cancer Center
Philadelphia, Pennsylvania, 19111
Urology San Antonio
San Antonio, Texas, 78229
UCSF
San Francisco, California, 94115
Virginia Mason Med. Crt.
Seattle, Washington, 98101
Seattle Cancer Care Alliance
Seattle, Washington, 98109
West Coast Clinical Research
Tarzana, California, 91356
Carle Cancer Center
Urbana, Illinois, 61801
About this study
Official title: A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer
The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.
- Conditions
- Prostate Cancer
- Being tested
- Immunotherapy allogeneic GM-CSF secreting cellular vaccine
- Keywords
- Prostate, Cancer, Advanced Prostate Cancer, Metastatic, Hormone-refractory, GVAX, Vaccine, Allogeneic cells
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy allogeneic GM-CSF secreting cellular vaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startDec 2001
- Study completionApr 2005
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Cell Genesys
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140348
- Sponsor's protocol ID
- G-0010
- Status last verified
- Dec 2007
- First submitted
- 30 Aug 2005
- Last updated
- 24 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00140348
- Acronym / sponsor ID
- G-0010
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Advanced Prostate Cancer, Metastatic, Hormone-refractory, GVAX, Vaccine, Allogeneic cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Cell GenesysIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Study completion
- Apr 2005 (actual)
- First posted
- 1 Sep 2005 (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 study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of adenocarcinoma of the prostate
- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
- Detectable metastases
- ECOG performance status of 0 or 1
Key exclusion criteria (3 listed)
- Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- Significant cancer related pain
- Prior gene therapy, chemotherapy, or immunotherapy
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 |
|---|---|---|
| Immunotherapy allogeneic GM-CSF secreting cellular vaccine | Biological | – |
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 24 Dec 2007.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Immunotherapy allogeneic GM-CSF secreting cellular vaccine in people with Prostate Cancer, run by Cell Genesys at 12 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 24 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 24 Dec 2007.