Lymphoma Clinical Trial
Official title:
Phase I Trial of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder (4-HPR/LXS Oral Powder) (4-HPR) in Adults With Solid Tumors and Lymphomas
RATIONALE: Drugs used in chemotherapy, such as fenretinide Lym-X-Sorb™ , work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them
from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide
Lym-X-Sorb™ in treating patients with recurrent or resistant solid tumors or lymphoma.
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of fenretinide Lym-X-Sorb™ oral powder
(4-HPR/LXS oral powder) in patients with recurrent and/or resistant solid tumors or
lymphomas.
- To define the toxicities of 4-HPR/LXS oral powder in these patients.
- To determine the plasma pharmacokinetics of 4-HPR/LXS oral powder in these patients.
Secondary
- To determine the level of fenretinide delivered as 4-HPR/LXS oral powder in normal
peripheral blood mononuclear cells.
OUTLINE: This is a multicenter study.
Patients receive oral fenretinide Lym-X-Sorb™ oral powder (4-HPR/LXS oral powder) (mixed in
food carriers) three times daily on days 1-7. Treatment repeats every 21 days for 6 courses
in the absence of disease progression or unacceptable toxicity. Patients achieving stable
disease response or better may receive additional courses of treatment at the discretion of
the treating physician and principal investigator.
Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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