Clinical Trial: Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma.
Detailed Summary:
OBJECTIVES:
- Determine the progression-free survival rate in patients with low-risk embryonal rhabdomyosarcoma treated with intensive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide followed by vincristine and dactinomycin.
OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Sponsor: Japan Rhabdomyosarcoma Study Group
Current Primary Outcome: Disease-free survival at 3 years after study registration
Original Primary Outcome:
Current Secondary Outcome:
- Overall survival at 3 years after study registration
- Toxicity by NCI CTC at 3 years after study registration
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: October 25, 2005
Date Started: May 2004
Date Completion:
Last Updated: August 9, 2013
Last Verified: July 2009
