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A Safety and Efficacy Study of Intravenous 131I-TM601 in Adult Patients With Malignant Melanoma

NCT00733798 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2009-05-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive and/or recurrent malignant melanoma.

Conditions

Interventions

DRUG

131I-TM601

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.

Sponsors & Collaborators

  • TransMolecular

    lead INDUSTRY

Principal Investigators

  • Thomas Gribbin, MD · Lacks Cancer Center

  • Neil Senzer, MD · Mary Crowley Cancer Center

  • Anna Pavlick, DO · New York University Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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 NCT00733798 on ClinicalTrials.gov