Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
Malignancies, B-Cell Lymphoma
About this trial
This is an interventional treatment trial for Malignancies focused on measuring advanced solid malignancies, B-cell lymphoma, Aroplatin, L-NDDP, MTD, advanced solid malignancies or B-cell lymphoma
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.