Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)

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Research

Protocol

RST531: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)

Diseases

Solid Tumor : Rhabdomyosarcoma

Description

Rhabdomyosarcoma (RMS) is the most common soft tissue cancer in children and adolescents. Participants in this research study have tumors that are considered an intermediate risk tumor. The term “risk” refers to the chance of the cancer coming back after treatment. Results from past studies indicate there is about a 35 percent chance that the tumor will return after treatment.

The normal treatment for intermediate-risk rhabdomyosarcoma is surgery, anti-cancer drug therapy (chemotherapy), and radiation therapy (treatment with high energy x-rays). The standard chemotherapy includes vincristine, dactinomycin and cyclophosphamide (known as VAC).

In this research study doctors want to determine if adding an additional drug combination will improve the outcome for the participants. This drug combination is vincristine plus irinotecan and is referred to as VI. The doctors will also look at the effectiveness of giving radiation therapy earlier in the treatment schedule. The study will also evaluate if a lower dose of cyclophosphamide is as effective in treating RMS, but with fewer bad effects during and after treatment.

Objectives

To determine if the new combination (VAC plus VI) is better than standard chemotherapy (VAC) alone for treating intermediate risk RMS
To compare the effects, good and bad, of a new combination (VAC plus VI) of chemotherapy
To compare a new schedule to the standard schedule for giving radiation therapy
To compare the side effects of a slightly lower dose to the higher standard dose of cyclophosphamide

Eligibility

Participant has newly diagnosed intermediate risk embryonal RMS (rhabdomyosarcoma), botryoid or spindle cell variants of embryonal RMS, ectomesenchymoma, or alveolar RMS
Participant has not received prior chemotherapy or radiation therapy
Participant meets established guidelines for adequate function of the bone marrow, liver and kidney
Participant is able to perform ordinary tasks and daily activities as defined in the study guidelines
Participant meets other requirements defined in the eligibility portion of the 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 Spunt, MD
St. Jude Children’s Research Hospital
332 N. Lauderdale
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

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.

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