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131-I-TM-601 Study in Adults With Solid Tumors

NCT00379132 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-03-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

131-I-TM-601 (chlorotoxin)

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)

Sponsors & Collaborators

  • TransMolecular

    lead INDUSTRY

Principal Investigators

  • John Fiveash, MD · University of Alabama at Birmingham

  • Jeffrey Raizer, M.D. · Northwestern University

  • Neil Senzer, MD · Mary Crowley Medical Research Center

  • Thomas Gribbins, MD · Lacks Cancer Center at St. Mary's Health Care

  • Jay-Jiguang Zhu, MD · Tufts Medical Center

  • Steven Chmura, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00379132 on ClinicalTrials.gov