Protocol

RST8P1: A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab[IMC-A12, Anti-IGF-IR Monoclonal Antibody, IND #100947, NSC # 742460]) inCombination with Intensive Multi-Agent Interval Compressed Therapy for Patients with High-Risk Rhabdomyosarcoma

Diseases

Solid Tumor : Rhabdomyosarcoma

Description

Rhabdomyosarcoma or a similar tumor called ectomesenchymoma is a type of cancer that occurs in the soft tissues in children and adolescents, and affects a few hundred children in the United States each year. Currently, more than 70% of children with localized rhabdomyosarcoma can be cured of their disease with treatment that includes surgical removal of tumor (when possible), anti-cancer drugs (chemotherapy), and high energy x-rays (radiation therapy). Children with rhabdomyosarcoma that has spread to other parts of the body from where it started have a poor prognosis. Only about 25% of these patients can be cured.

The standard drugs used for rhabdomyosarcoma are vincristine, actinomycin D and cyclophosphamide, and are often called VAC therapy. Past studies have been done using higher doses of cyclophosphamide but that has not increased the treatment success for high risk patients. Recent studies have added other drugs to standard VAC therapy while giving the drugs more often. The additional chemotherapy drugs are ifosfamide, etoposide, doxorubicin and irinotecan. The combination of the standard VAC therapy and these additional drugs may lead to more cures in high-risk patients. This study is designed to see if adding two additional drugs (Cixutumumab and Temozolomide) to multi-drug chemotherapy is well tolerated.

Objectives

• To find out the effects, good and/or bad, of giving Cixutumumab in combination with high intensity chemotherapy to participants with high risk rhabdomyosarcoma or ectomesenchymoma.
• To find out the effects, good and/or bad, of giving Temozolomide in combination with high intensity chemotherapy to participants with high risk rhabdomyosarcoma or ectomesenchymoma.
• To find out the effects, good and/or bad, of giving both Cixutumumab and Temozolomide in combination with high intensity chemotherapy to participants with high risk rhabdomyosarcoma or ectomesenchymoma.
• To see if adding either Cixutumumab or Temozolomide or both drugs will get rid of the cancer for as long as possible for high risk rhabdomyosarcoma participants.

Eligibility

• Patient with newly diagnosed, rhabdomyosarcoma or ectomesenchymoma are eligible for this study.
• For embryonal RMS: Age ≥ 10 years and < 50 years at the time of enrollment and for alveolar RMS or ectomesenchymoma: Age < 50 years at the time of enrollment.No prior chemotherapy or radiotherapy except for use of corticosteroids or emergent radiation therapy. Patients requiring emergency radiation are eligible.
• Patients with metastatic embryonal RMS and age < 10 years are eligible.
• Female patients who are pregnant are not eligible.
• Female patients who are breastfeeding are not eligible. Female patients who are lactating must agree to stop breastfeeding to participate in this study.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Sheri L. Spunt, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
Voice: 1-888-226-4343 or 901-595-4055
Fax: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.