Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma

B-Cell Lymphoma Clinical Trial

Official title: A Phase 1 Multi-Center, Dose Escalation and Pharmacokinetic Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a dose escalation study that utilizes a constant incremental dose increase of 50 mg/m2 per cohort. 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. DLT is defined as any adverse event (AE) of severity grade 3, 4 or 5 (including serious or life-threatening) considered possibly, probably or definitely related to L-NDDP (CTCAE v3.0), which occurs during cycle 1, excluding those events that occur and are completely resolved within 4-6 hours of the first dose of L-NDDP (infusion-related reactions). This study also aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP, defined as the dose level at which no more than one out of six patients has any DLT. Once the MTD has been determined, an additional four patients will be enrolled at that dose level (for a total of 10 patients at the MTD 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 through whole blood, plasma, and urine samples drawn before, during, and after L-NDDP administration. Clinical activity of L-NDDP in solid tumor patients will be assessed as tumor response using the RECIST criteria. Clinical activity of L-NDDP in B-Cell lymphoma patients will be assessed using the International Working Group Recommendations. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Malignancies
• Neoplasms

• NCT number: NCT00316511
• Study type: Interventional
• Source: Agenus, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: March 2006