Lymphoma Clinical Trial
Official title:
A Phase 1 Trial of the Combination of Everolimus (RAD001) and Bortezomib (VELCADE) for Relapsed or Refractory Lymphoma
RATIONALE: Everolimus and bortezomib may stop the growth of cancer cells by blocking some of
the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when
given together with bortezomib in treating patients with relapsed or refractory lymphoma.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of everolimus (up to 10 mg PO daily) in
combination with bortezomib in patients with relapsed/refractory indolent or mantle
cell non-Hodgkin's lymphoma (NHL) including cutaneous forms, or relapsed/refractory
aggressive NHL ineligible for hematopoetic stem cell transplantation
Secondary
- Evaluate the toxicity of this combination.
- Assess the pharmacokinetics interactions between these agents.
- Assess the response rate and 6-month progression-free survival in treated patients.
- Obtain preliminary data to assess associations between tumor characteristics and
response to treatment. in those subjects who underwent biopsy prior to study treatment.
OUTLINE: This is a dose-escalation study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Patients also receive oral
everolimus once daily or once every other day on days 1-21 in all courses. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
Patients will undergo blood sample collection on Cycle 1, Day 11 for pharmacokinetic
studies. Baseline tumor expression of mTOR and NFkB -related proteins (i.e., pS6K, pAKT, and
cREL) and FOXP3 is assessed by immunohistochemistry.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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