Status:
TERMINATED
Tissue Procurement Substudy for Participants in Study CP-MGA271-01
Lead Sponsor:
MacroGenics
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to gain a better understanding about how the study drug MGA271 works. No test drug will be given in this study. Patients with easily accessible tumors at the screening vis...
Detailed Description
Patients with easily accessible tumors (generally, metastatic deposits involving skin, subcutaneous tissues, or peripheral lymph node whose excision would not require general anaesthesia or the invasi...
Eligibility Criteria
Inclusion
- Qualified, by meeting all inclusion and exclusion criteria, for participation in Study CP-MGA271-01.
- Must have provided informed consent to participate in Study CP-MGA271-01.
- Must have accessible tumors (generally speaking, metastatic deposits involving skin, subcutaneous tissue, or peripheral lymph node whose excision, punch biopsy, or core needle biopsy would not require general anaesthesia or the invasion of a body cavity).
- Willing to undergo two minor surgical procedures with no expectation of personal benefit
- Have provided Informed Consent for this substudy as indicated by a signature on an approved consent document obtained from the patient or his/her legally authorized representative
Exclusion
- Any medical condition that would contraindicate the use of local or locoregional anaesthesia, or conscious sedation for the intended minor surgical procedure.
- Any medical condition (eg. skin disease or bleeding diathesis) that would hinder wound healing following a minor surgical procedure.
- Dementia or altered mental status that would preclude understanding and rendering of informed consent.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01918930
Start Date
July 1 2013
End Date
October 1 2016
Last Update
February 8 2022
Active Locations (7)
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1
UCLA Hematology-Oncology Clinic
Los Angeles, California, United States, 90095
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
The University of Chicago
Chicago, Illinois, United States, 60637
4
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114