This phase I/II trial studies the side effects, maximum tolerated dose, and effectiveness of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients with recurrent or refractory Hodgkin or B-cell non-Hodgkin lymphoma. More effective and well tolerated therapies are needed to treat patients with relapsed and refractory lymphomas. Nab-paclitaxel combines a chemotherapeutic agent with a protein which may increase the anticancer drug concentration in the tumor while reducing toxic effects in normal tissue and may be an effective treatment for lymphoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
St. Louis University School of Medicine
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Phase I: Maximum tolerated dose (MTD) of Abraxane in patients with recurrent or refractory lymphoma
Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.
Time frame: 28 days (completion of cycle 1) for all patients in Phase I portion
Phase I: Dose-limiting toxicities (DLTs) of Abraxane in patients with recurrent or refractory lymphoma
Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4
Time frame: 28 days (completion of cycle 1)
Phase II: Overall response rate (CR + PR)
Time frame: 24 weeks (end of study)
Phase I: Toxicity associated with Abraxane
Time frame: 28 weeks (30 days after completion of study treatment)
Phase II: Time to progression.
Response and progression will be recorded with each imaging evaluation according to the 2007 revised response criteria for malignant lymphoma by Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-86.
Time frame: 24 weeks (end of study)
Phase II: Duration of remission
Time frame: 24 weeks (end of study)
Phase II: Overall survival.
Time frame: 3 years
Phase II: Clinical benefit (CR + PR + SD)
Time frame: 24 weeks (end of study)
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