Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
Lay 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 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 chemotherapy plus temsirolimus is more effective than chemotherapy alone in treating patients with intermediate-risk rhabdomyosarcoma.
Category
- Soft Tissue
- IRB Number
- 20160538HU
- NCT Number
- NCT02567435
Eligibility
- Eligible Ages
- Under40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Feasibility Phase: Patients must be < 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1 - Efficacy Phase: Patients must be =< 40 years of age at the time of enrollment - 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 embryonal rhabdomyosarcoma (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 World Health Organization (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 alveolar rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and includes classic and solid variants - ERMS - Stage 1, group III (non-orbit) - Stage 3, group I/II - Stage 2/3, group III - Stage 4, group IV, < 10 years old - ARMS: - Stages 1-3, groups I-III - Specimen Submission: Patients must have sufficient tissue available for the required biology study - Lansky performance status score >= 50 for patients =< 16 years of age; Karnofsky performance status score >= 50 for patients > 16 years of age - Peripheral absolute neutrophil count (ANC) >= 750/uL - Platelet count >= 75,000/uL - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: - 1 month to < 6 months old: 0.4 mg/dl (male), 0.4 mg/dl (female) - 6 months to < 1 year old: 0.5 mg/dl (male), 0.5 mg/dl (female) - 1 to < 2 years old: 0.6 mg/dl (male), 0.6 mg/dl (female) - 2 to < 6 years old: 0.8 mg/dl (male), 0.8 mg/dl (female) - 6 to < 10 years old: 1 mg/dl (male), 1 mg/dl (female) - 10 to < 13 years old: 1.2 mg/dl (male), 1.2 mg/dl (female) - 13 to < 16 years old: 1.5 mg/dl (male), 1.4 mg/dl (female) - >= 16 years old: 1.7 mg/dl (male), 1.4 mg/dl (female) - Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible; however, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (i.e. percutaneous nephrostomies or ureteric stents) of the urinary tract - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age - All patients and/or their parents or legal guardians must sign a written informed consent. - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Virginia Diaz
210-562-9149
diazvr@uthscsa.edu
Jaclyn Hung
210-450-5358
hungj@uthscsa.edu
Principal Investigator
Anne-Marie Langevin