Lymphoma Clinical Trial
Official title:
A Phase I Study of ABT-888 in Combination With Metronomic Cyclophosphamide in Adults With Refractory Solid Tumors and Lymphomas
RATIONALE: ABT-888 may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in
different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. Giving ABT-888 together with cyclophosphamide may kill more
cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of ABT-888 when given
together with cyclophosphamide in treating patients with solid tumors or lymphoma that did
not respond to previous therapy.
OBJECTIVES:
- Establish the safety and tolerability of ABT-888 when administered in combination with
metronomic cyclophosphamide in patients with refractory solid tumors or lymphoma.
- Establish the maximum tolerated dose of ABT-888 when administered in combination with
metronomic cyclophosphamide in these patients.
- Evaluate the pharmacokinetics of ABT-888 when administered in combination with
metronomic cyclophosphamide in these patients.
- Evaluate the antitumor response in these patients.
- Determine the effects of treatment on the level of PARP inhibition and γ-H2AX in blood
and tumor samples from these patients.
OUTLINE: This is a multicenter, dose-escalation study of ABT-888.
Patients receive oral ABT-888 once daily for 7-21 days and oral cyclophosphamide once daily
for 14 or 21 days. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Plasma samples are collected periodically for pharmacodynamic and pharmacokinetic analysis.
Samples are analyzed for PAR concentration by immunoassay, γ-H2AX levels by
immunocytochemistry, quantification of the γ-H2AX marker and co-localization markers via
quantitative immunofluorescence analysis, and ABT-888 concentration by liquid
chromatography/mass spectrometry.
After completion of study therapy, patients are followed for 30 days.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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