A Phase 1/2, Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Melanoma
This is a multi-center, Phase 1/2 study evaluating the use of multiple intravenous doses of
131I-TM601 in adults patients with progressive and/or recurrent malignant melanoma (Stage
IIIc or IV) with measurable disease who have failed first line/standard therapy.
The study will be conducted in 2 phases. During the first, Dose Escalation Phase, eligible
patients wil be assigned in groups of 3-6 (depending upon the treatment response seen at
each dose) to dose cohorts of between 2-5 weekly IV doses of 131I-TM601. Escalation to the
next highest dose during the Dose Escalation Phase will be dependent upon demonstrated
tolerance in the previous dosing group. In the second, Efficacy Phase, all patients will be
treated with the Maximum Tolerated Dose determined in the Dose Escalation Phase.
Prior to initiating treatment, all patients will be administered a single imaging dose of
131I-TM601, IV, as an Imaging Dose to evaluate tumor uptake. Only patients demonstrating
tumor uptake will remain on the study.
Patients in both study phases will have safety parameters evaluated continuously throughout
the study. Clinical response to 131I-TM601 will be assessed in each study patient at 28
days following the final study dose, and then at 2-month intervals, starting at 3 months
following the first study dose (during the first year of follow-up), and finally at 3-month
intervals thereafter until disease progression.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety profile, as evaluated by incidence, severity, duration, causality, and seriousness of adverse events as well as by changes in patient's physical examination, vital signs, and clinical laboratory assessments.
duration of the study
Thomas Gribbin, MD
Lacks Cancer Center
United States: Food and Drug Administration
|New York University School of Medicine||New York, New York 10016|
|Lacks Cancer Center||Grand Rapids, Michigan 49503|
|Mary Crowley Cancer Center||Dallas, Texas 75246|