Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pain Therapeutics

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.