Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Michigan Cancer Center |
---|---|
Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00743509 |
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.
Condition | Intervention | Phase |
---|---|---|
Osteosarcoma |
Drug: Cyclophosphamide and Sirolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma |
Estimated Enrollment: | 47 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | January 2015 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
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
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cancer AnswerLine | 800-865-1125 |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Cancer AnswerLine 800-865-1125 | |
Principal Investigator: Scott Schuetze, MD, PhD |
Principal Investigator: | Scott Schuetze, MD, PhD | University of Michigan Cancer Center |
Responsible Party: | University of Michigan Comprehensive Cancer Center ( Scott Schuetze, MD, PhD - Principal Investigator ) |
Study ID Numbers: | UMCC 2008.049 |
Study First Received: | August 27, 2008 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00743509 |
Health Authority: | United States: Food and Drug Administration |
sarcoma Cyclophosphamide Sirolimus Progressive or recurrent, advanced (unresectable or metastatic) high-grade osteosarcoma, Ewing's or soft tissue sarcoma previously treated with chemotherapy. |
Sirolimus Neoplasms, Connective and Soft Tissue Clotrimazole Miconazole Malignant mesenchymal tumor Tioconazole |
Sarcoma Osteosarcoma Cyclophosphamide Osteogenic sarcoma Soft tissue sarcomas Recurrence |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents |
Neoplasms Neoplasms, Bone Tissue Antifungal Agents Therapeutic Uses Myeloablative Agonists Neoplasms, Connective Tissue Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |