A Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma
The purpose of this Phase II study will assess the effectiveness of the combination of oral cyclophosphamide and sirolimus in sarcoma patients with relapsed or widespread disease who cannot be cured by surgery, radiation or conventional chemotherapy.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma|
- Progression-free Survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Patients who were evaluable for response to therapy, alive and without evidence of sarcoma disease progression. Target lesions followed were lesions that had progressed by World Health Organization (WHO) criteria.
- Overall Survival [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]Patients who were still alive for assessment of lesions as defined by the World Health Organization (WHO) scale after 12 cycles or 48 weeks
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Oral Cyclophosphamide and Sirolimus (OCR)
Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.
Drug: Cyclophosphamide and Sirolimus
The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.
Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously
Other Name: Sirolimus (rapamycin, Rapamune)
The purpose of this Phase II study you are being asked to participate in will assess the effectiveness of the combination of oral cyclophosphamide and sirolimus in sarcoma patients with relapsed or widespread disease who cannot be cured by surgery, radiation or conventional chemotherapy. Malignant connective tissue tumors of soft tissue and bone (sarcomas) are highly aggressive cancers. There are few available chemotherapy treatments that are active in treating sarcomas. Sarcomas that have metastasized (spread throughout the body) are usually fatal. There is a great need to identify new active drugs to treat metastatic or relapsed sarcomas. Low dose oral daily cyclophosphamide is an established chemotherapy regimen for treatment of malignant and autoimmune disease and is generally well tolerated. Sirolimus is approved for prevention of kidney rejection after transplantation. Temsirolimus, a form of sirolimus, is approved for the treatment of kidney cancer. Sirolimus combined with cyclophosphamide in animal models of sarcoma resulted in significant anti-tumor activity. Tumor and blood samples will be studied to look for known protein targets of the medication to help learn why certain subjects have a favorable response to the treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743509
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Scott Schuetze, MD, PhD||University of Michigan Cancer Center|