A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)
In this study, researchers want to find out if we can improve the treatment for subjects (people who agree to take part in this study) with intermediate risk rhabdomyosarcoma (RMS) by adding an experimental drug called temsirolimus to standard therapy, called VAC/VI.
Regimen A: VAC/VI: Vincristine/Dactinomycin/Cyclophosphamide/Irinotecan
Regimen B: VAC/VI plus temsirolimus: Vincristine/Dactinomycin/Cyclophosphamide/Irinotecan PLUS Tersirolimus
Regimen C: VAC/VA: Vincristine/Dactinomycin/Cyclophosphamide followed by Vincristine/Dactinomycin
Phase 3 study with Vincristine/Dactinomycin/Cyclophosphamide/Irinotecan versus Vincristine/Dactinomycin/Cyclophosphamide/Irinotecan with Temsirolimus for patients with Rhabdomyosarcoma
Must be ≤ 40 years of age
Newly diagnosed RMS of any subtype, except adult-type pleomorphic
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.
Adequate bone marrow, renal and liver function
No prior treatment with temsirolimus, another mTOR inhibitor, or any other investigational agent
No prior chemotherapy (excluding steroids) and/or Radiation therapy
No uncontrolled hyperglycemia or uncontrolled hyperlipidemia
Male and Female patients must use adequate birth control
Can not be pregnant or breastfeeding
Applicable Disease Sites
Bladder; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid
Gundersen Health System; UW Hospital and Clinics