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Hematology/Oncology Research Studies: Open for Enrollment | Date: 01/26/21 |
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| NCT#/Phase: | NCT02567435 Phase 3 |
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| IRB#: | 2017-122 |
| Description: | This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy or combination chemotherapy plus temsirolimus is more effective in treating patients with intermediate-risk rhabdomyosarcoma. |
| Inclusion: | Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon Stage, Group, and age, as below. RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2013 WHO Classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Classification of ARMS in the 2013 WHO Classification is the same as in the ICR and includes classic and solid variants. |
| Enrollment Status: | Open for enrollment |
| Sponsor: | COG |
| Principal Investigator(s): | Carla Golden, MD |
| Contact(s): | Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611) COG CRA Office (510-428-3885 x8334) |
| Study Link: | https://clinicaltrials.gov/ct2/show/NCT02567435 |