NCT00070304

Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma

A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	Given by mouth or IV, 5 micrograms/kg/dose (up to 10 micrograms/kg/dose) daily starting on day 9 for a minimum of 7 days and until the ANC is greater to or equal to 1,500/uL.
DRUG	gemcitabine hydrochloride	Given IV over 100 minutes dose 1000 mg/m2/dose in 500 ml NS on days 1 and 8
DRUG	vinorelbine tartrate	Given IV over 6-10 minutes (central venous catheter). Dose 25 mg/m2/dose on days 1 and 8

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-09-01
• First posted: 2003-10-07
• Last updated: 2013-07-26

Locations

123 sites across 5 countries: United States, Australia, Canada, Puerto Rico, Switzerland