Lymphoma Clinical Trial
Official title:
A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, use different
ways to stop cancer cells from dividing so they stop growing or die. Combining more than one
drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with
vinorelbine works in treating young patients with recurrent or refractory Hodgkin's
lymphoma.
OBJECTIVES:
- Determine the response rate of pediatric patients with recurrent or refractory
Hodgkin's lymphoma treated with gemcitabine and vinorelbine.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on
days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day
9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every
21 days for at least 2 courses in the absence of disease progression or unacceptable
toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell
transplantation off study OR receive 2 additional courses. Patients with stable disease
after 2 courses receive at least 2 additional courses. Patients with continued stable or
responding disease (with no disease progression) after 4 courses may continue to receive
study treatment for up to 1 year or discontinue study for alternative therapy at the
discretion of the treating physician.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 1.5
years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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