Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
NCT00399113 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2011-07-14
Summary
The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order to provide information on how the monoclonal antibody is distributed throughout the body and to assess tumor targeting. No therapeutic dose of radiation will be given in the first study.
Conditions
Interventions
- DRUG
-
188Re-PTI-6D2
monoclonal antibody
Sponsors & Collaborators
-
Pain Therapeutics
lead INDUSTRY
Principal Investigators
-
Eithan Galun, M.D. · Hadassah Hebrew University Hospital
-
Jacob Schachter, M.D. · Chaim Sheba Medical Center
-
Tzila Zwas, M.D. · Chaim Sheba Medical 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
- Start
- 2007-05-31
- Primary Completion
- 2008-06-30
Countries
- Israel
Study Locations
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