Clinical trial NCT01918930: Tissue Procurement Substudy for Participants in Study CP-MGA271-01
Official title: A Tissue Procurement and Examination Substudy of Study CP-MGA271-01 (NCT01391143)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Melanoma
Keywords: Melanoma
Accessible tumors
B7-H3 positive tumors
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
First posted: 2013-08-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 visit for participation in Study CP-MGA271-01 will be asked to participate in this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle biopsies.

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 invasion of a body cavity) at the screening visit for participation in Study CP-MGA271-01 (the main study) will be asked to participate in this substudy. After providing appropriate informed consent, patients will undergo excisional biopsy, punch biopsy, or core needle biopsy of the accessible tumor prior to receiving study drug in the main study and then again after the first cycle of study drug is completed.

Some of the biopsy tissue will be sent to a central laboratory for research purposes. The central lab will analyze the tissue to see what effects that the study drug might have on tumors.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Mechanism of Action
timeFrame: up to 50 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hematology-Oncology Clinic
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Huntersville
country: United States
facility: Carolina BioOncology Institute
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: MacroGenics
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: