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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborators: |
National Comprehensive Cancer Network Wyeth |
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00949325 |
Purpose
The purpose of this study is to identify a safe dosing regimen for the combination of Torisel and liposomal doxorubicin in patients with recurrent sarcoma. A secondary purpose of the study is to determine how effective this combination is for the treatment of recurrent sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: temsirolimus (Torisel) plus liposomal doxorubicin (Doxil) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas |
| Estimated Enrollment: | 45 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Temsirolimus plus Liposomal Doxorubicin: Experimental |
Drug: temsirolimus (Torisel) plus liposomal doxorubicin (Doxil)
Patients will be treated with temsirolimus weekly by iv and with liposomal doxorubicin by iv every 28 days. Initial dosing will be with standard doses for each drug, but dosing will be modified based on toxicity.
|
The effectiveness of treatments for recurrent sarcomas is quite limited. One hypothesis to explain the refractory nature of recurrent sarcomas is the existence of chemotherapy-resistant sarcoma stem cells.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Margaret F Ferreira, RN, BSN | 410-955-7349 | mfogle1@jhmi.edu |
| Contact: Tammy Scott, RN, BSN | 410-614-5990 | scottta@jhmi.edu |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Principal Investigator: | David M Loeb, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Responsible Party: | Johns Hopkins University ( David M. Loeb, MD, PhD ) |
| Study ID Numbers: | J0963, NA_00028490 |
| Study First Received: | July 28, 2009 |
| Last Updated: | September 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00949325 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
osteosarcoma soft tissue sarcoma rhabdomyosarcoma leiomyosarcoma Ewing's sarcoma chondrosarcoma liposarcoma |
malignant fibrous histiocytoma malignant peripheral nerve sheath tumor pleiomorphic sarcoma spindle cell sarcoma synovial sarcoma cancer stem cell |
|
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Sarcoma Doxorubicin Antibiotics, Antineoplastic Pharmacologic Actions |