Lymphoma Clinical Trial
Official title:
A Phase I/II Study of the Raf Kinase/VEGFR Inhibitor Sorafenib in Combination With the mTOR Inhibitor RAD001 (Everolimus) in Patients With Relapsed Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Multiple Myeloma
RATIONALE: Sorafenib and everolimus may stop the growth of cancer cells by blocking blood
flow to the cancer and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib and
everolimus and to see how well they work in treating patients with relapsed or refractory
non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of sorafenib tosylate and everolimus in
patients with relapsed or refractory non-Hodgkin's lymphoma, Hodgkin's lymphoma, or
multiple myeloma.
- Determine the toxicity of this regimen in these patients.
- Evaluate the therapeutic activity of this regimen in these patients.
- Evaluate the pharmacokinetic interaction of this regimen.
- Correlate clinical (toxicity and/or tumor response or activity) effects with
pharmacologic (pharmacokinetic/pharmacodynamic) parameters and/or biologic (correlative
laboratory) results.
OUTLINE: This is a multicenter, dose-escalation, phase I study followed by a phase II study.
- Phase I (closed to accrual as of 2/10/2009): Patients receive oral sorafenib tosylate
and oral everolimus on days 1-28. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of sorafenib tosylate and everolimus until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that
at which at least 2 out of at most 6 patients experience a Dose Limiting Toxicity (DLT).
- Phase II: Patients receive oral sorafenib tosylate twice daily and oral everolimus once
daily at the MTD determined in phase I. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Blood and bone marrow are collected periodically during the study and analyzed by flow
cytometry, immunohistochemistry, and enzyme-linked immunosorbent assay. Patients enrolled in
phase I also undergo blood sample collection on days 8 and 15 during course 1 and on day 1 of
each subsequent course for pharmacokinetic studies.
After completion of study treatment, patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 103 patients will be accrued for this study.
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