Prostate CancerPhase 2NCT00274287
GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere
A Phase 2 study testing GM CSF in people with Prostate Cancer, run by Oncology Specialists, S.C. at 1 site in United States.
Trial summary
This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- GM CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men >18 years of age. No upper age limit
- Written informed consent approved by institutional review board should be explained to and signed by patient
- Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason score of any sum is allowed on this study.
- Metastatic disease as evidenced by visceral involvement, bone disease, or PSA elevation.
- Patients should meet the criteria of androgen independent prostate cancer (AIPC). Patients would fulfill these criteria if they continue to progress despite complete androgen blockade (surgical or medical castration with anti-androgen) and despite an anti-androgen withdrawal trial. Failing anti-androgen withdrawal is defined as no decline by 25% or more 3-weeks after stopping anti-androgens.
- Progression on hormonal therapy is defined as ANY of the following:
Show all 25Show fewer
- PSA: 2 consecutive rising PSA values, at least 14-days apart, each being > 5 ng/ml
- For patients with visceral measurable disease, progression is defined as an increase by 50% or more in the size of measurable areas, or any development of new lesions.
- For patients with bone-only disease, progression is defined as the appearance of 2 or more new areas of abnormal uptake on a bone scan, when compared to prior imaging studies. Changes in the uptake of already existing lesions will NOT be used to define progressive disease.
- For patients with bone AND visceral disease, fulfilling any of the criteria in 5.2 or 5.3 is sufficient to define progression.
- Castration levels of testosterone (< 50 ng/dl) achieved via medical or surgical castration. Patients should continue on LHRH agonists throughout if this is the method used to achieve castration.
- Life expectancy of at least 6 months
- Adequate hematologic, renal, and liver function as evidenced by the following:
- WBC > 2000,
- ANC > 1000,
- Platelet count > 100,000,
- HgB > 9.0 g/dl, Creatinine < 2,
- Total bilirubin < 2x upper limit of normal,
- AST and ALT < 3 x upper limit of normal
- ECOG performance status of 0 or 1.
- The use of intravenous polyphosphates for bone metastases is allowed.
- upon completion of the taxotere portion of study, patient can be enrolled \& receive GM-CSF if ANY of the following criteria is met:
- Patients received total of 8 cycles of taxotere \& have no signs of disease progression
- Patients achieved their maximal response despite receiving < than 8 cycles of taxotere. Maximum response is defined as a drop in measures of PSA by 10% or less on 2 consecutive measurements.
- Patients who have completed their chemotherapy < than 12 weeks prior to opening this trial \& still have stable disease without progression (by PSA and radiographically) will be eligible to receive maintenance GM-CSF
Who cannot join
- presence of brain metastases
- Known HIV+ status
- ECOG performance status of 2 or higher
- Use of investigational agents within 4 weeks of starting
- Patients with prior exposure to more than one chemotherapy program Patients who have received one chemotherapy schedule can be enrolled on study and receive GM-CSF (the maintenance arm) if their last chemotherapy was taxotere, given within the past 12 weeks, and they have demonstrated NO evidence of progression radiographically and biochemically. Prior exposure to steroids is NOT an exclusion criteria.
- Patients with other active malignancies (excluding non-melanoma skin cancers)are excluded. Prior malignancies are not exclusion criteria as long as last treatment for such malignancies was over 5 years prior to enrollment.
- Treatment with investigational products are NOT an exclusion criteria, if therapy was last received over 4 weeks prior to enrollment.
- Any medical intervention or other condition which, in the opinion of the principle investigator, could compromise adherence with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oncology Specialists, SC
Park Ridge, Illinois, 60068
About this study
Official title: A Phase II Pilot Study Investigating the Efficacy and Activity of Single Agent GM-CSF (Leukine) Maintenance Approach in Androgen-independent Prostate Cancer (AIPC) Patients Responding to Taxotere Chemotherapy
This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule.
Read the detailed description
Patients will be treated on this single arm, open label trial until primary end point is met, patient's withdrawal, or investigator's discretion. After achieving a maximal response on taxotere or other chemo schedule they were eligible to enroll in this trial and begin treatment with maintenance GMCSF for 2 weeks followed by 2 weeks of rest. Once progression was documented the patients were taken off study.
- Conditions
- Prostate Cancer
- Being tested
- GM CSF
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM CSFDrug
Also called Leukine
250 ug/m2 daily for 2 weeks followed by 2 weeks of rest
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF | Experimental | Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GM-CSF as outlined in the protocol Receives: Drug: GM CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression (TTP)
The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported
Measured: up to 21 months
Secondary outcomes (4)
Response Rate (PSA)
Biochemical PR (Partial Response) was defined as a PSA that decreases by 50% and maintains by at least 3 weeks by confirmatory measurement. Biochemical SD (stable disease) was defined as a PSA that was increased by less than 25% or decreased by less than 50% Biochemical PD (progressive disease) was defined as an increase of at least 25% confirmed 3 weeks after.
Measured: up to 21 months
Response Rate (Radiographic)
PR was defined as more than 30% decrease in the sum of the longest diameter of measurable lesions compared to baseline. SD was defined when lesions did not meet criteria for PR or PD. PD was defined as more than 20% increase in the sum of the longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions at imaging studies. The appearance of 2 or more new boney lesions on bone scan development of cord compression, and pathologic fractures constituted PD.
Measured: up to 21 months
Median Overall Survival (OS)
Measured: up to 44 months
Median Number of GM-CSF Cycles
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncology Specialists, S.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
- Investigators
- Chadi Nabhan, MD, Principal investigator, Oncology Specialists, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274287
- Sponsor's protocol ID
- 0412
- Status last verified
- Mar 2019
- First submitted
- 6 Jan 2006
- Last updated
- 28 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nabhan C, Meyer A, Tolzien K, Bitran JD, Lestingi TM. A phase II pilot trial investigating the efficacy and activity of single agent granulocyte macrophage colony-stimulating factor as maintenance approach in castration - resistant prostate cancer patients responding to chemotherapy. Avicenna J Med. 2011 Jul;1(1):12-7. doi: 10.4103/2231-0770.83718.
PubMed 23210004
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study Investigating the Efficacy and Activity of Single Agent GM-CSF (Leukine) Maintenance Approach in Androgen-independent Prostate Cancer (AIPC) Patients Responding to Taxotere Chemotherapy
- ClinicalTrials.gov ID
- NCT00274287
- Acronym / sponsor ID
- 0412
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oncology Specialists, S.C.University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Jan 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Jan 2006 (estimated)
- Results
- Posted 9 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule.
Detailed description
Patients will be treated on this single arm, open label trial until primary end point is met, patient's withdrawal, or investigator's discretion. After achieving a maximal response on taxotere or other chemo schedule they were eligible to enroll in this trial and begin treatment with maintenance GMCSF for 2 weeks followed by 2 weeks of rest. Once progression was documented the patients were taken off study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GM-CSF | Experimental | Drug: GM CSFOnce patients have finished receiving the chemotherapy and no signs of disease progression they may receive GM-CSF as outlined in the protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Men >18 years of age. No upper age limit
- Written informed consent approved by institutional review board should be explained to and signed by patient
- Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason score of any sum is allowed on this study.
- Metastatic disease as evidenced by visceral involvement, bone disease, or PSA elevation.
- Patients should meet the criteria of androgen independent prostate cancer (AIPC). Patients would fulfill these criteria if they continue to progress despite complete androgen blockade (surgical or medical castration with anti-androgen) and despite an anti-androgen withdrawal trial. Failing anti-androgen withdrawal is defined as no decline by 25% or more 3-weeks after stopping anti-androgens.
Key exclusion criteria (8 listed)
- presence of brain metastases
- Known HIV+ status
- ECOG performance status of 2 or higher
- Use of investigational agents within 4 weeks of starting
- Patients with prior exposure to more than one chemotherapy program Patients who have received one chemotherapy schedule can be enrolled on study and receive GM-CSF (the maintenance arm) if their last chemotherapy was taxotere, given within the past 12 weeks, and they have demonstrated NO evidence of progression radiographically and biochemically. Prior exposure to steroids is NOT an exclusion criteria.
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 |
|---|---|---|
| GM CSFAlso: Leukine250 ug/m2 daily for 2 weeks followed by 2 weeks of rest | Drug | GM-CSF |
Primary outcome
Time to Disease Progression (TTP)
Time frame: up to 21 months
The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported
4 secondary outcomes
Response Rate (PSA)
Time frame: up to 21 months
Response Rate (Radiographic)
Time frame: up to 21 months
Median Overall Survival (OS)
Time frame: up to 44 months
Median Number of GM-CSF Cycles
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23210004Nabhan C, Meyer A, Tolzien K, Bitran JD, Lestingi TM. A phase II pilot trial investigating the efficacy and activity of single agent granulocyte macrophage colony-stimulating factor as maintenance approach in castration - resistant prostate cancer patients responding to chemotherapy. Avicenna J Med. 2011 Jul;1(1):12-7. doi: 10.4103/2231-0770.83718.
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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.
Chadi Nabhan, MD principal investigator
Oncology Specialists, SC
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 GM CSF in people with Prostate Cancer, run by Oncology Specialists, S.C. at 1 site 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 25 inclusion and 8 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 28 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 9 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Disease Progression (TTP) (time frame: up to 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00274287, which also lists 1 linked publication.
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 28 Mar 2019.