🏛️ Verified NIH Record • Updated 2026-08-27

Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (NCT02567435)

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) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (28 items) and avoid the listed exclusions (8 items).

Location: Children's Hospital of Alabama — Birmingham, Alabama

Age range: Not specified to 40 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients who have previously received temsirolimus, another mTOR inhibitor, or any other investigational agent
  • Patients who have received any chemotherapy (excluding steroids) and/or RT prior to this enrollment
  • Patients with uncontrolled hyperglycemia
  • Patients with uncontrolled hyperlipidemia
  • Sexually active patients 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
  • Female patients who are pregnant are not eligible since fetal toxicities or teratogenic effects have been noted for several of the study drugs; Note: A pregnancy test is required for female patients of childbearing potential prior to study entry
  • Lactating females who plan to breastfeed their infants are not eligible

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (382 Sites)

Showing the first 25 of 382 sites.

  • Children's Hospital of Alabama — Birmingham, Alabama
  • USA Health Strada Patient Care Center — Mobile, Alabama
  • Anchorage Associates in Radiation Medicine — Anchorage, Alaska
  • Anchorage Radiation Therapy Center — Anchorage, Alaska
  • Alaska Breast Care and Surgery LLC — Anchorage, Alaska
  • Alaska Oncology and Hematology LLC — Anchorage, Alaska
  • Alaska Women's Cancer Care — Anchorage, Alaska
  • Anchorage Oncology Centre — Anchorage, Alaska
  • Katmai Oncology Group — Anchorage, Alaska
  • Providence Alaska Medical Center — Anchorage, Alaska
  • Kingman Regional Medical Center — Kingman, Arizona
  • Banner Children's at Desert — Mesa, Arizona
  • Phoenix Childrens Hospital — Phoenix, Arizona
  • Mayo Clinic Hospital in Arizona — Phoenix, Arizona
  • Mayo Clinic in Arizona — Scottsdale, Arizona
  • Banner University Medical Center - Tucson — Tucson, Arizona
  • Arkansas Children's Hospital — Little Rock, Arkansas
  • Kaiser Permanente-Anaheim — Anaheim, California
  • PCR Oncology — Arroyo Grande, California
  • Kaiser Permanente-Bellflower — Bellflower, California
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
  • Kaiser Permanente Downey Medical Center — Downey, California
  • Kaiser Permanente-Fontana — Fontana, California
  • Loma Linda University Medical Center — Loma Linda, California
  • Children's Hospital Los Angeles — Los Angeles, California

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Alveolar Rhabdomyosarcoma

Explore by condition: All Alveolar Rhabdomyosarcoma clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗