A Safety and Efficacy Study of Intravenous 131I-TM601 in Adult Patients With Malignant Melanoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1/2, Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Melanoma|
- 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. [ Time Frame: duration of the study ] [ Designated as safety issue: Yes ]
- 6 month progression-free survival [ Time Frame: duration of study ] [ Designated as safety issue: No ]
- Clinical response, time to disease progression, and overall survival. [ Time Frame: duration of study ] [ Designated as safety issue: No ]
After a single 20mCi/0.4 mg Imaging Dose of 131I-TM601, patients in the Dose Escalation Phase will be administered between 2-5 weekly doses of 131I-TM601 at 1.2 mCi/kg of lean body mass (specific activity of 131I-TM601 will be maintained at 50 mCi 131I/mg TM601 for all doses administered in this study.) Patients in the Efficacy Phase of the study will be treated at the Maximum Tolerated Dose established in the Dose Escalation Phase.
Other Name: chlorotoxin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733798
|United States, Michigan|
|Lacks Cancer Center|
|Grand Rapids, Michigan, United States, 49503|
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|United States, Texas|
|Mary Crowley Cancer Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Thomas Gribbin, MD||Lacks Cancer Center|
|Principal Investigator:||Neil Senzer, MD||Mary Crowley Cancer Center|
|Principal Investigator:||Anna Pavlick, DO||New York University Cancer Center|