Phase 1 TheraSphere + Everolimus With Neuroendocrine Tumors (NETs) + Liver Only or Liver Dominant Disease

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2014

Primary Completion Date

May 31, 2018

Conditions
Liver Cancer
Interventions
OTHER

TheraSphere

TheraSphere glass microspheres containing Y-90 injected into catheter, and will deliver 120 Gy to entire tumor bearing portion of the liver given at a single session on Cycle 1 Day 15.

DRUG

Everolimus

"Starting dose: is 5 mg by mouth daily for cycles 1 and 2. Patients will receive standard dose of Everolimus at 10 mg by mouth daily starting cycle 3 day 1.~Dose Expansion Cohort Starting Dose: Maximum tolerated dose from dose escalation cohort."

OTHER

Phone Call

At least 1 time a week by phone or at the clinic for up to 30 days after last everolimus dose, study staff will follow up. Patient asked about any side effects they may have had. The call should last about 10-15 minutes.

All Listed Sponsors
collaborator

BTG International Inc.

OTHER

collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER