drugset / Trial / NCT01555853

Phase I/II Study of Abraxane in Recurrent and Refractory Lymphoma

NCT01555853 ↗

Phase 1 Terminated 20 enrolled Washington University School of Medicine
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-07
Primary completion
2016-06
Completion
2016-06

Outcome

Outcome not reported

Stopped (Enrollment): “completed accrual to phase I but drug did not show activity, so halted before initiation of phase II”

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Paclitaxel Small molecule 150 mg/m2 Intravenous