MelanomaPhase 2NCT00043368
PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)
A Phase 2 study testing PF-3512676 in people with Melanoma and Breast Neoplasms, run by Pfizer at 32 sites in 2 countries.
Trial summary
This protocol allows patients who completed Coley oncology studies using PF-3512676 (CPG 7909) Injection to continue receiving the treatment until disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Breast Neoplasms, Carcinoma, Renal Cell
- What is being tested?
- PF-3512676
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Sep 2002to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Immediate (within 4 weeks) prior completion of a clinical trial of PF-3512676 Injection alone or in combination with other anti-neoplastic treatment for malignancy.
Who cannot join
- The patient has received any anti-neoplastic therapy since completing a prior trial with PF-3512676 Injection, or has participated in another clinical trial following participation in a trial with PF-3512676 Injection.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States31 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Asheville, North Carolina, 28801
Pfizer Investigational Site
Berkely, California, 94704
Pfizer Investigational Site
Bonita Springs, Florida, 34135
Pfizer Investigational Site
Bradenton, Florida, 34209
Pfizer Investigational Site
Cape Coral, Florida, 33990
Pfizer Investigational Site
Chicago, Illinois, 60611-3124
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Collierville, Tennessee, 38107
Pfizer Investigational Site
Fort Myers, Florida, 33901
Pfizer Investigational Site
Fort Myers, Florida
Pfizer Investigational Site
Gilroy, California, 95020
Pfizer Investigational Site
Hollister, California, 95023
Pfizer Investigational Site
Livingston, New Jersey, 07039
Pfizer Investigational Site
Los Angeles, California, 90057
Pfizer Investigational Site
Los Angeles, California, 91342
Pfizer Investigational Site
Memphis, Tennessee, 38017
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Naples, Florida, 34102
Pfizer Investigational Site
New Haven, Connecticut, 06504
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Oxford, Mississippi, 38655
Pfizer Investigational Site
Palm Springs, California, 92262
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Port Charlotte, Florida, 33980
Pfizer Investigational Site
Portland, Oregon, 97213
Pfizer Investigational Site
Sarasota, Florida, 34232
Pfizer Investigational Site
Stanford, California, 94305
Pfizer Investigational Site
Venice, Florida, 34285
Pfizer Investigational Site
Venice, Florida, 34292
Pfizer Investigational Site
Vincennes, Indiana, 47591
About this study
Official title: A Continuation Study Of PF-3512676 (CPG 7909) Injection In Patients With Metastatic Or Recurrent Malignancies Who Have Stable Disease Or Who Have Responded To Pf-3512676 Injection Therapy
This protocol allows patients who completed Coley oncology studies using PF-3512676 (CPG 7909) Injection to continue receiving the treatment until disease progression.
- Conditions
- Melanoma, Breast Neoplasms, Carcinoma, Renal Cell, Lymphoma, T-Cell, Carcinoma, Non-Small-Cell Lung
- Being tested
- PF-3512676
- Keywords
- CPG 7909 continuation study
- Medical subject headings
- Melanoma, Breast Neoplasms, Carcinoma, Renal Cell, Lymphoma, T-Cell, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-3512676Drug
Also called CPG 7909, ProMune
PF-3512676 IV at doses: 0.01mg/kg, 0.16mg/kg and 0.32mg/kg PF-3512676 Injection given by subcutaneous injection at doses: 0.04mg/kg, 0.16mg/kg, 0.20mg/kg, 0.28mg/kg, 0.32mg/kg, 6mg, 10mg, 40mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will be treated with the same dosing regimen and schedule of PF-3512676 Injection with which they were treated at the end of the previous PF-3512676 Injection trial. Any proposed changes to their schedule/regimen will be at the discretion of the treating physician, following consultation with Coley. Receives: Drug: PF-3512676 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events and DLTs will be evaluated by the Investigator and summarized.
Measured: indeterminate
Secondary outcomes (1)
No formal statistical analysis of this study will be conducted. All clinical data may be summarized and included in data listings.
Measured: indeterminate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2002 (estimated)
- Study startSep 2002
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043368
- Sponsor's protocol ID
- C016
- Other IDs
- CO16, A8501015
- Status last verified
- Mar 2009
- First submitted
- 8 Aug 2002
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continuation Study Of PF-3512676 (CPG 7909) Injection In Patients With Metastatic Or Recurrent Malignancies Who Have Stable Disease Or Who Have Responded To Pf-3512676 Injection Therapy
- ClinicalTrials.gov ID
- NCT00043368
- Acronym / sponsor ID
- C016
- Conditions
- Melanoma, Breast Neoplasms, Carcinoma, Renal Cell, Lymphoma, T-Cell, Carcinoma, Non-Small-Cell Lung
- Keywords
- CPG 7909 continuation study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 12 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.
This protocol allows patients who completed Coley oncology studies using PF-3512676 (CPG 7909) Injection to continue receiving the treatment until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PF-3512676Patients will be treated with the same dosing regimen and schedule of PF-3512676 Injection with which they were treated at the end of the previous PF-3512676 Injection trial. Any proposed changes to their schedule/regimen will be at the discretion of the treating physician, following consultation with Coley. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Immediate (within 4 weeks) prior completion of a clinical trial of PF-3512676 Injection alone or in combination with other anti-neoplastic treatment for malignancy.
Key exclusion criteria (1 listed)
- The patient has received any anti-neoplastic therapy since completing a prior trial with PF-3512676 Injection, or has participated in another clinical trial following participation in a trial with PF-3512676 Injection.
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 |
|---|---|---|
| PF-3512676Also: CPG 7909, ProMunePF-3512676 IV at doses: 0.01mg/kg, 0.16mg/kg and 0.32mg/kg PF-3512676 Injection given by subcutaneous injection at doses: 0.04mg/kg, 0.16mg/kg, 0.20mg/kg, 0.28mg/kg, 0.32mg/kg, 6mg, 10mg, 40mg. | Drug | 1 |
Primary outcome
Adverse Events and DLTs will be evaluated by the Investigator and summarized.
Time frame: indeterminate
1 secondary outcome
No formal statistical analysis of this study will be conducted. All clinical data may be summarized and included in data listings.
Time frame: indeterminate
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 12 Mar 2009.
- To obtain contact information for a study center near you, click here.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.
Pfizer CT.gov Call Center study director
Pfizer
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-3512676 in people with Melanoma and Breast Neoplasms, run by Pfizer at 32 sites in 2 countries.
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 1 inclusion and 1 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 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Germany. 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.
What does the primary outcome measure?
Adverse Events and DLTs will be evaluated by the Investigator and summarized. (time frame: indeterminate). It is what the study was designed to measure, not a finding.
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 12 Mar 2009.