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

Completed · Phase 1

Conditions studied: Malignancies, B-Cell Lymphoma

In brief

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.

Key facts

Study ID: NCT00316511
Run by: Agenus Inc.
People needed: 21
Starts: 2006-03-01
Last updated by the study team: 2008-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Advanced solid malignancies or B-cell lymphoma
Less than or equal to 5 anti-cancer treatment regimens, which must be concluded at least four weeks prior to the first planned L-NDDP administration
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
New York Heart Association (NYHA) Class I or II
Greater than or equal to 18 years of age
Absolute neutrophil count greater than or equal to 1.5 x 10\^9/L
Platelets greater than or equal to 100 x 10\^9/L
Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
ALT less than 3 x ULN in absence of liver metastases; less than 5 x ULN in presence of liver metastases.
Hemoglobin greater than or equal to 10 g/dL
Total bilirubin less than or equal to 2 x ULN
Female of childbearing potential must have a negative serum pregnancy test
Male or female patients of child producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for one month after the last L-NDDP dose.
Signed written informed consent must be obtained and documented according to ICH-GCP, the local regulatory requirements, and the rules followed at each institution.

You may not qualify if…

Known active or untreated brain metastases
Other ongoing systemic cancer therapies
Hypersensitivity to platinum compounds
Other active malignancies with the exception of adequately treated in-situ carcinoma of the uterine cervix, or non-melanoma skin cancer
A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration [at least two assessments at a minimum of 48 hours apart] of a QTc interval of > 450 for males and > 470 for females) or history of additional risk factors for torsades des pointes or use of concomitant medication prolonging the QT/QTc interval
Serious illness which, in the opinion of the Principal Investigator, would prevent study completion
Investigational therapy currently or within four weeks prior to planned first dose of L-NDDP
Women who are pregnant or breastfeeding will be excluded from participation.

Where it is running

Study site — Boston, Massachusetts, United States
Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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