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A Phase II Trial of Irinotecan plus Carboplatin, and Irinotecan Maintenance Therapy Integrated into the Upfront Therapy of Newly Diagnosed Patients with Intermediate- and High-Risk Rhabdomyosarcoma

[Protocol 03-099]

Full Title :
A PILOT PHASE II TRIAL OF IRINOTECAN PLUS CARBOPLATIN, AND IRINOTECAN MAINTENANCE THERAPY (HIGH-RISK PATIENTS ONLY), INTEGRATED INTO THE UPFRONT THERAPY OF NEWLY DIAGNOSED PATIENTS WITH INTERMEDIATE-AND HIGH-RISK RHABDOMYOSARCOMA
Purpose :

Rhabdomyosarcoma is a cancer of muscle tissue. Patients with this cancer are categorized into "risk groups" based on the chances that the tumor can be cured. In determining a patient's risk group, doctors consider his/her age, how the tumor looks under the microscope, where the tumor started, tumor size, how much tumor remains after surgery, and whether the tumor has spread. Patients with intermediate-risk rhabdomyosarcoma have a 30 to 70 percent chance of a cure with routine treatment, while those with the high-risk form of the cancer have a 15 to 30 percent chance of a cure.

This research study is evaluating a treatment that includes seven chemotherapy drugs plus radiation therapy and/or surgery. Five of the drugs have been helpful in many patients with rhabdomyosarcoma. Three drugs are given at higher doses than those used at most other hospitals. The study also uses two new drugs -- irinotecan plus carboplatin -- given together. Both of these drugs have been used in children and adults with different types of cancer. This drug combination is investigational because it has not been used before in patients newly diagnosed with rhabdomyosarcoma.

In this phase II protocol, investigators want to determine: how effective irinotecan plus carboplatin is in newly diagnosed patients with rhabdomyosarcoma, and observe any side effects; see if irinotecan plus carboplatin can be safely given during radiation treatment; and determine if adding irinotecan plus carboplatin to the five other chemotherapy drugs can cure more patients with intermediate-risk and high-risk rhabdomyosarcoma. Among the patients with high-risk disease, researchers also want to determine if giving 4 months of irinotecan at the end of treatment can be done safely and without bad side effects, and if it can lower the amount of "angiogenesis factors" in the blood (substances which promote the growth of blood vessels that tumors need to grow and spread).

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed, previously untreated rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma that is determined to be intermediate-risk or high-risk. Patients may not have had prior chemotherapy or radiation therapy.
  • Patients must be age 30 or younger at the time of diagnosis.

For more information and to see if you are eligible for this study, please contact Dr. Leonard H. Wexler at 212-639-7990 or Dr. Paul Meyers at 212-639-5952.

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