Status:
COMPLETED
Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
Lead Sponsor:
Pain Therapeutics
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 inf...
Detailed Description
This study will evaluate the safety and feasibility of the administration of 188Re-PTI-6D2 in patients with metastatic melanoma. Patients with confirmed Stage IIIc (unresectable) or Stage IV melanoma ...
Eligibility Criteria
Inclusion
- Histologically confirmed Stage IIIc (unresectable) or Stage IV metastatic melanoma;
- measurable disease;
- at least 18 years of age;
- Karnofsky status at least 50%;
- life expectancy \> 3 months;
- at least 4 weeks since prior therapy;
- adequate organ and marrow function defined by screening laboratory tests;
- negative screening human anti-murine antibodies;
- females of child-bearing potential must be practicing an acceptable method of birth control and have a negative urine pregnancy test;
- written informed consent obtained
Exclusion
- Chemotherapy or radiation therapy within 4 weeks or poor recovery from therapy \> 4 weeks ago;
- investigational drug within 30 days;
- brain metastasis (all patients must have contrast-enhanced MRI within 2 weeks of treatment to rule out);
- ocular inflammatory disease or ocular neoplasm (all patients must have fundoscopic and slit lamp examination within 2 weeks of treatment to rule out exclusionary ocular pathology);
- prior parenteral exposure to murine proteins;
- positive hep B surface Ag, hep C antibody, or HIV test at screening;
- uncontrolled intercurrent illness;
- pregnant/breast-feeding.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00399113
Start Date
May 1 2007
Last Update
July 14 2011
Active Locations (2)
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1
Hadassah Hebrew University Hospital
Jerusalem, Israel, 91120
2
Chaim Sheba Medical Center
Tel Litwinsky, Israel, 52621