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)

Overview

The purpose of this study is to compare the event-free survival of patients with IR RMS treated with surgery, radiotherapy and VAC alternating with VI (VAC/VI) to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus (TORI).

Description

The purpose of this study is to compare the event-free survival of patients with IR RMS treated with surgery, radiotherapy and VAC alternating with VI (VAC/VI) to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus (TORI).

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: rhabdomyosarcoma
  • Age: - 40 Years
  • Gender: Male or Female

Inclusion Criteria
Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification
Patients must have sufficient tissue available for the required biology study
Adequate bone marrow function
Adequate renal function
Adequate liver function
Exclusion Criteria
Patients who have previously received TORI, another mTOR inhibitor, or any other investigational agent
Patients who have received any chemotherapy (excludign steroids) and/or radiation therapy prior to this enrollment
Patients with uncontrolled hyperglycemia
Patients with hyperlipidemia
Sexually active patient of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for at least 3 months after treatment is completed if sexually active with reproductive potential
Pregnant or breastfeeding (lactating)


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022 . Study ID: TX7509

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