Safety Study of MGA271 in Refractory Cancer

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01391143 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-217

 

The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Keith Flaherty, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed carcinoma, melanoma, or glioblastoma that overexpresses B7-H3. - Progressive disease during or after last treatment regimen. - Appropriate treatment history for histological entity. - ECOG Performance Status <= 1. - Life expectancy >= 3 months. - Measurable disease or evaluable disease with relevant tumor marker elevation. - Acceptable laboratory parameters and adequate organ reserve. Exclusion Criteria: - Evidence of adrenal insufficiency by rapid Cosyntropin stimulation test (patients with glioblastoma who have or are receiving steroids in past 4 months will be exempted from this exclusion). - Major surgery or trauma within four weeks before enrollment. - Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation. - History of autoimmune disease associated with ipilimumab therapy. - Second primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score < 6), or resected melanoma in situ are exceptions and do not require a 3 year remission. - Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment. - Vaccination within 2 weeks of enrollment (except for annual flu vaccine). - History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.
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