drugset / Trial / NCT00837200

Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

NCT00837200

Phase 2 Terminated 13 enrolled Milton S. Hershey Medical Center
NaSingle-groupOpen-labelTreatment

Summary

This is an exploratory study to study the efficacy of combination regimen of Oncaspar/Doxil/Decadron (ODD) in patients with refractory lymphoid malignancies. Patients with any form of lymphoid malignancy will be eligible: acute lymphoblastic leukemia, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma and plasma cell leukemia. Patients must have failed standard regimens for their cancers and could have had unlimited number of prior regimens. Patients will be staged appropriately for their disease with clinical examination, laboratory tests, and imaging studies. Both Oncaspar and Doxil will be given on day 1 and 15. Patients will be clinically evaluated prior to each cycle and will have disease assessments every 2 cycles. Responding patients will continue therapy until disease progression or excessive toxicity. Responders who are candidates for allogenic stem cell transplantation could go to conditioning chemotherapy and stem cell transplant after 4 cycles of ODD.

Timeline

Start
2009-03
Primary completion
2011-01
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 20 mg Oral
Subject Doxorubicin Other / unclassified 20 mg/m2 Intravenous
Subject Pegaspargase Protein / enzyme biologic 2500 unknown Intravenous