CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 target
Drug / intervention
131-I-TM-601 (chlorotoxin)drug
Likely dose
131-I-TM-601 (chlorotoxin) 0.2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00379132
NCT00379132Phase 1Completed
CompareCT.gov

A Phase I Imaging and Safety Study of Intravenous 131-I-TM-601 Labeled Chlorotoxin in Patients With Recurrent or Refractory Somatic and/or Cerebral Metastatic Solid Tumors

TransMolecular·interventional·Posted Sep 21, 2006·Updated Mar 31, 2009

In Brief

A Phase 1 clinical trial evaluating 131-I-TM-601 (chlorotoxin) for Breast Cancer and 7 related conditions. Completed, enrolled 60 participants across 6 sites.

Detailed Summary

This study is designed to evaluate the ability of intravenously (IV)administered 131-I-labeled TM-601 (chlorotoxin) to provide tumor-specific localization(via radiographic imaging) in patients with recurrent or refractory primary solid tumors with evidence of metastatic involvement. (Refractory tumors are non-responsive to standard treatment.) The safety and tolerability of IV administered 131-I-TM-601 in this patient population will be evaluated as part of this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Non-Small Cell Lung Cancer, Melanoma, Colorectal Cancer, Pancreatic Cancer, Prostate Adenocarcinoma, Glioma, Primary Solid Tumors
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2006
Enrollment StartAug 1, 2006
Primary CompletionJul 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.8 years ago

Interventions

131-I-TM-601 (chlorotoxin)drug

Patients will be administered 1 - 3 (Test Doses A, B, and Dose C) escalating doses of 131I-TM601 by intravenous (IV) administration. Each dose will be administered as a single administration, scheduled at one-week intervals. Test Dose A - 10 mCi (+/- 20%)/0.2 mg TM601 (131I-TM601) Test Dose B - 20 mCi (+/- 20%)/0.4 mg TM601 (131I-TM601) Dose C - 30 mCi (+/- 10%)/0.6 mg TM601 (131I-TM601)