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)
Investigating Treatment Options for Intermediate-Risk RMS
Brief description of study.
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).
Detailed description of study
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: rhabdomyosarcoma
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Age: 40 years or below
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Gender: All
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)
This study investigates the event-free survival of patients with intermediate-risk rhabdomyosarcoma (IR RMS), a type of cancer that forms in soft tissue, treated with different combinations of surgery, radiotherapy, and chemotherapy. The study compares two treatment arms: one involving surgery, radiotherapy, and a chemotherapy regimen called VAC/VI, and the other involving the same treatment with the addition of an investigational medication.
Participants in this study will undergo standard cancer treatments such as surgery and radiotherapy. Additionally, they will receive chemotherapy, which involves the use of drugs to kill cancer cells. The study will compare the outcomes of those receiving the investigational medication along with the standard treatment to those receiving only the standard treatment.
- Who can participate: Patients with newly diagnosed rhabdomyosarcoma (RMS), excluding adult-type pleomorphic, can participate. They must have adequate bone marrow, renal, and liver function, and provide sufficient tissue for study. Those who have received certain treatments or have specific health conditions are excluded.
- Study details: Participants will undergo surgery, radiotherapy, and chemotherapy. Some will also receive an investigational medication. A placebo is not used in this study.
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