Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00477087|
Recruitment Status : Terminated (Low accrual)
First Posted : May 22, 2007
Results First Posted : November 29, 2017
Last Update Posted : November 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Mitoxantrone Drug: GM-CSF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||January 2010|
Experimental: GM-CSF Plus Mitoxantrone
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.
Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.
Other Name: NovantroneDrug: GM-CSF
GM-CSF is a biologic response modifier, classified as a colony stimulating factor.
- 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)
- Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response) [ Time Frame: 18 months ]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.
- Overall Survival (OS) [ Time Frame: 18 months ]Assessed as the time from the 1st dose of study drug to death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477087
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dr. Sandy Srinivas||Stanford University|