An Open-Label Phase I Safety, Pharmacokinetic & Dosimetry Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
18 Years
N/A
Both
Metastatic Melanoma
Trial Information
An Open-Label Phase I Safety, Pharmacokinetic & Dosimetry Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
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 who meet all eligibility criteria will undergo a thorough physical
examination and baseline tumor imaging (whole body 18FDG PET/CT and MRI brain) to document
all sites of tumor.
Treatment will be administered on an inpatient basis. An initial cohort of 3 patients will
receive a tracer dose of 188Re-PTI-6D2 without any preceding unlabeled antibody. The tracer
dose will consist of 10 mCi of rhenium-labeled antibody; the amount of antibody (in mg) will
depend on specific activity and is estimated to range from 2 to 10 mg. Additional cohorts of
three patients each will receive 10 mg, 20 mg, and 50 mg of unlabeled PTI-6D2 immediately
preceding administration of the tracer dose. Patients will undergo serial gamma scans and
SPECT/CT imaging at specified time points. Blood samples will be obtained prior to dosing
and at specified intervals for PK measurements of the mAb as well as for measurement of
serum radioactivity. Urine will also be collected for all patients to measure excreted
radioactivity. Patients will be closely monitored for safety throughout the duration of the
study.
Patients will remain at the study center for 48 hours after infusion to allow adequate time
for post-treatment safety observation, monoclonal antibody clearance and rhenium decay.
Prior to the escalation of the dose of unlabeled PTI-6D2, safety data from the inpatient
period and 2-week follow-up visit for the three patients at the current dose level will be
reviewed. If there is no evidence of a safety risk, the dose of unlabeled PTI-6D2 will be
escalated for the next cohort of patients. Dose escalation of unlabeled antibody will occur
according to a specific scheme.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To select the amount of unlabeled PTI-6D2 to administer immediately prior to a tracer dose of 188Re-PTI-6D2 in order to achieve preferred tumor targeting
Principal Investigator
Eithan Galun, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hadassah Hebrew University Hospital
Authority:
Israel: Ministry of Health
Study ID:
PTI-6D2-A
NCT ID:
NCT00399113
Start Date:
May 2007
Completion Date:
Related Keywords:
- Metastatic Melanoma
- Melanoma
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