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Protocol No. ARST1431

Principal Investigator DeSantes, Kenneth

Phase III

Age Group Both

Scope National

Sponsor Type Institutional; National

Title 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)

Objective 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

Description Phase 3 study with Vincristine/Dactinomycin/Cyclophosphamide/Irinotecan versus Vincristine/Dactinomycin/Cyclophosphamide/Irinotecan with Temsirolimus for patients with Rhabdomyosarcoma

Key Eligibility
  • 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

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics