Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
An Open-Label Phase I Safety, Pharmacokinetic & Dosimetry Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
1 other identifier
interventional
12
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedJuly 14, 2011
July 1, 2011
1.1 years
November 13, 2006
July 12, 2011
Conditions
Outcome Measures
Primary Outcomes (3)
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
To generate pharmacokinetic (PK) and biodistribution data of 188Re-PTI-6D2 in patients with metastatic melanoma in order to estimate radiation doses absorbed to tumor and critical organs
To determine the frequency of HAMA response associated with 188Re-PTI-6D2 administration
Interventions
monoclonal antibody
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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);
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hadassah Hebrew University Hospital
Jerusalem, 91120, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eithan Galun, M.D.
Hadassah Hebrew University Hospital
- PRINCIPAL INVESTIGATOR
Jacob Schachter, M.D.
Chaim Sheba Medical Center
- PRINCIPAL INVESTIGATOR
Tzila Zwas, M.D.
Chaim Sheba Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 13, 2006
First Posted
November 14, 2006
Study Start
May 1, 2007
Primary Completion
June 1, 2008
Last Updated
July 14, 2011
Record last verified: 2011-07