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|
|Primary Completion Date :||October 2009|
|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.
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|