Prostatic NeoplasmsPhase 2NCT00477087
Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer
A Phase 2 study testing Mitoxantrone and GM-CSF in people with Prostatic Neoplasms, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Mitoxantrone and GM-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jan 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Age ≥ 18 years
- Histologically-confirmed adenocarcinoma of the prostate
- Hormone-refractory prostate cancer
- Failed 1st-line docetaxel-containing regimen
- No prior immunotherapy including:
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- Vaccines
- GM-CSF
- Minimum prostate-specific antigen (PSA) > 5 mg/dL and rising according to the PSA Consensus Criteria
- Karnofsky Performance Status (KPS) > 60%
- Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
- Life expectancy > 6 months
Who cannot join
- Concomitant hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonist
- Use of herbal products known to decrease PSA levels
- Use of supplements or complementary medicines, except for:
- Conventional multivitamin supplements
- Selenium
- Lycopene
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- Soy supplements
- Vitamin E
- Initiation of bisphosphonates within one month prior to enrollment or throughout the study
- Any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment
- Major surgery or radiation therapy completed < 4 weeks prior to enrollment
- Any concomitant second malignancy other than non-melanoma skin cancer
- Any concomitant serious infection
- Any nonmalignant medical illness
- Absolute neutrophil count (ANC) < 1,500/µL
- Platelet count < 100,000 µL
- Hemoglobin < 8 mg/dL
- Total bilirubin greater than 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN if no demonstrable liver metastases, or greater than 5.0 x ULN in presence of liver metastases
- Ejection fraction < 50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
- Noncompliance with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer
The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.
Read the detailed description
This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. Because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and therefore both drugs will be given at standard (approved) doses.
- Conditions
- Prostatic Neoplasms
- Being tested
- Mitoxantrone, 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.
MitoxantroneDrug
Also called Novantrone
Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.
GM-CSFDrug
Also called Sargramostim, Leukine, Granulocyte-Macrophage Colony Stimulating Factor
GM-CSF is a biologic response modifier, classified as a colony stimulating factor.
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF Plus Mitoxantrone | Experimental | GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days. Receives: Drug: Mitoxantrone; Drug: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Assessed as the time from the 1st dose of study drug to death or disease progression (increase >25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of >20% KPS)
Measured: 18 months
Secondary outcomes (2)
Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)
Defined as the first evidence of a total serum PSA decline of > 50% from baseline, maintained for at least 28 days, and confirmed with 2 consecutive measurements taken 2 weeks apart.
Measured: 18 months
Overall Survival (OS)
Assessed as the time from the 1st dose of study drug to death.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startJul 2006
- Primary completionOct 2009
- Study completionJan 2010
Why it stopped: Low accrual
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.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Sandy Srinivas, Stanford University
- Investigators
- Dr. Sandy Srinivas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477087
- Sponsor's protocol ID
- IRB-04738
- Other IDs
- 96817, PROS0017
- Status last verified
- Oct 2017
- First submitted
- 18 May 2007
- Last updated
- 29 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00477087
- Acronym / sponsor ID
- IRB-04738
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jul 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Posted 29 Nov 2017
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 the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.
Detailed description
This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. Because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and therefore both drugs will be given at standard (approved) doses.
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 Plus Mitoxantrone | Experimental | Drug: Mitoxantrone, Drug: GM-CSFGM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed written informed consent
- Age ≥ 18 years
- Histologically-confirmed adenocarcinoma of the prostate
- Hormone-refractory prostate cancer
- Failed 1st-line docetaxel-containing regimen
Key exclusion criteria (21 listed)
- Concomitant hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonist
- Use of herbal products known to decrease PSA levels
- Use of supplements or complementary medicines, except for:
- Initiation of bisphosphonates within one month prior to enrollment or throughout the study
- Any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment
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 |
|---|---|---|
| MitoxantroneAlso: NovantroneMitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic. | Drug | GM-CSF Plus Mitoxantrone |
| GM-CSFAlso: Sargramostim, Leukine, Granulocyte-Macrophage Colony Stimulating FactorGM-CSF is a biologic response modifier, classified as a colony stimulating factor. | Drug | GM-CSF Plus Mitoxantrone |
Primary outcome
Progression-free Survival (PFS)
Time frame: 18 months
Assessed as the time from the 1st dose of study drug to death or disease progression (increase >25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of >20% KPS)
2 secondary outcomes
Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)
Time frame: 18 months
Overall Survival (OS)
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Dr. Sandy Srinivas principal investigator
Stanford University
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 Mitoxantrone and GM-CSF in people with Prostatic Neoplasms, run by Stanford University 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 12 inclusion and 21 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: stopped early, as of the sponsor's last update on 29 Nov 2017. 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 29 Nov 2017). 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?
Progression-free Survival (PFS) (time frame: 18 months). 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 29 Nov 2017.