A Phase 1 Study of Radiolabeled Monoclonal Antibody 7E11-C5.3(177Lu-meO-DOTA-7E11;CYT-500) in Patients With Progressive Androgen-Independent Prostate Cancer
The proposed phase I clinical trial will investigate the safety and tolerability of
177Lu-CYT-500 and determine the optimal antibody mass and dose of 177Lu to be used for
further study. The biodistribution and pharmacokinetics will also be assessed. Patients
with histologically documented prostate cancer that is progressing following castration will
be eligible. Two antibody masses will be explored in cohort 1 before dose escalation of the
177Lu begins. If the two antibody masses show no difference in pharmacokinetics or
biodistribution, then the lower of the doses will be used. The radiation dose will be
escalated in subsequent cohorts. Dose escalation will be permitted when the last patient
accrued to the previous cohort has demonstrated count recovery in cycle 1 such that DLT has
not been defined.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To investigate the safety and tolerability of treatment with 177Lu-CYT-500 in patients with progressive androgen-independent prostate cancer
Michael J Morris, M.D.
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
500Lu01
NCT00441571
February 2007
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |