Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is a dose escalation study. Patients will be enrolled in cohorts of three patients each,
and escalation of dose to the next cohort will be determined based on dose-limiting toxicity
(DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of
intravenous L-NDDP. Once the MTD has been determined, an additional four patients will be
enrolled at that dose level. While the MTD is determined based on safety data from each
cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional
cycles of L-NDDP at the same dose as their starting dose until documented progression,
unacceptable toxicity, or another off study criterion is met. Patients who have not met any
of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is
determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also
determine the pharmacokinetic profile of L-NDDP administration. Clinical activity of L-NDDP
in solid tumor patients will be assessed as tumor response using the Response Evaluation
Criteria in Solid Tumors (RECIST) criteria. Clinical activity of L-NDDP in B-cell lymphoma
patients will be assessed using the International Working Group recommendations.