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RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as ifosfamide and vinorelbine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may help ifosfamide and vinorelbine work better by making cancer cells more sensitive to the drugs. Giving bortezomib together with ifosfamide and vinorelbine may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with ifosfamide and vinorelbine works in treating young patients with Hodgkin's lymphoma that is recurrent or did not respond to previous therapy.
- Determine the efficacy and safety of bortezomib (as a chemosensitizing agent) in pediatric patients and young adults with primary refractory Hodgkin's lymphoma (HL) or HL in first relapse.
- Determine response rate in patients treated with bortezomib, ifosfamide, and vinorelbine ditartrate (IVB) and compare it to the historical response rate in patients treated with ifosfamide and vinorelbine ditartrate alone.
- Determine the overall response rate (complete and partial response) and induction success rate after 2 or 4 courses of therapy and the reinduction rate (complete response) after 4 courses of therapy.
- Determine the proportion of patients able to mobilize sufficient hematopoietic stem cells (CD34+) after 2 courses of IVB.
OUTLINE: This is a multicenter, open-label, pilot study.
Patients receive ifosfamide IV continuously over days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, bortezomib IV on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or peripheral blood stem cells (PBSC) are harvested. Treatment repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
filgrastim, bortezomib, ifosfamide, vinorelbine ditartrate
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:42:19-0400
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