Safety and Efficacy of VB-111 in Subjects With Advanced Differentiated Thyroid Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Head and Neck Cancer
NCT ID: NCT01229865 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-336

 

The purpose of this study is to examine the safety and evaluate the response of VB-111 on DTC.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Lori Wirth, MD, Massachusetts General Hospital

Site-responsible Investigators:

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

Eligibility Criteria

Inclusion Criteria: 1. Histologically or cytologically confirmed advanced DTC (papillary, follicular, Hurthle cell); 2. Absence of sensitivity to therapeutic radioiodine; 3. Measurable disease, defined as at least one non-bony lesion that can be accurately measured in at least one dimension as confirmed with spiral CT scan 4. Life expectancy >3 months; ECOG performance status (PS) 0, 1, or 2; Karnofsky performance status of ≥60%; 5. Subjects with a normal/acceptable hematological profile 6. Subjects with adequate renal function Exclusion Criteria: 1. Presence of any of the following: - Radiotherapy or chemotherapy <4 weeks prior to baseline visit; (Concurrent and/or prior therapy with octreotide will be allowed, provided tumor progression on this therapy has been demonstrated; Concurrent and/or prior therapy with biphosphonates will be allowed) - Radiotherapy to ≥25% of bone marrow; 2. Major surgery <4 weeks prior to baseline visit; 3. Any other ongoing investigational agents within 4 weeks before dosing; 4. Subjects who suffered from an acute cardiac event within the last 12 months, including myocardial infarction, cardiac arrythmia, admission for unstable angina, cardiac angioplasty, or stenting; 5. QTc prolongation (defined as QTc interval ≥500 msecs) or other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia); 6. Subjects with active vascular disease, either myocardial or peripheral; 7. Subjects with proliferative and/or vascular retinopathy; 8. Subjects with known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) other than related to tumor metastases; 9. Subjects with known CNS metastatic disease (Exception: Subjects with treated CNS metastases stable by radiographic examinations >6 months after definitive therapy administered, are eligible); 10. Subjects testing positive to one of the following viruses: HIV, HBV or HCV; 11. Any of the following conditions: - Serious or non-healing wound, ulcer, or bone fracture; - History of abdominal fistula, gastro-intestinal perforation, active diverticulitis, intra-abdominal abscess or gastro-intestinal tract bleeding within 6 months of dosing; - Any history of cerebrovascular accident (CVA) within 6 months of dosing; - Current use of therapeutic warfarin (Note: Low molecular weight heparin and prophylactic low-dose warfarin [INR<1.2 X ULN] are permitted); - History of bleeding disorder, including subjects with hemophilia, disseminated intravascular coagulation (DIC), or any other abnormality of coagulation potentially predisposing subjects to bleeding; - Poorly controlled depression or anxiety disorder, or recent (within the previous 6 months) suicidal ideation; 12. Subjects with an ongoing requirement for immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before dosing; 13. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
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