Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

Aroplatin

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.

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

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

Agenus Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma	NCT00316511	Malignancies B-Cell Lymphoma	Aroplatin	18 Years -	Agenus Inc.
Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma	NCT00316511	Malignancies B-Cell Lymphoma	Aroplatin	18 Years -	Agenus Inc.

Spots Global Cancer Trial Database for aroplatin

Every month we try and update this database with for aroplatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aroplatin

Every month we try and update this database with for aroplatin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aroplatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.