Status:
COMPLETED
Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
Lead Sponsor:
Agenus Inc.
Conditions:
Malignancies
B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed 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 ne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00316511
Start Date
March 1 2006
Last Update
October 27 2008
Active Locations (2)
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1
Boston, Massachusetts, United States
2
Houston, Texas, United States