Phase 1 Trial Using 131I MIBG and 90Y DOTATOC in a Dosimetrically Determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors.

NCT03044977 EARLY_PHASE1 ACTIVE_NOT_RECRUITING

This study is designed to identify the best tolerated doses of \[131\]Iodine-MIBG and \[90\]Yttrium-DOTATOC when co-administered to treat midgut neuroendocrine tumors. These drugs (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy. Currently, the safest and best tolerated doses of these drugs (when combined together) is unknown.

Details

Lead sponsor	David Bushnell
Phase	EARLY_PHASE1
Status	ACTIVE_NOT_RECRUITING
Enrolment	20
Start date	2017-05-07
Completion	2027-12

Conditions

• Neuroendocrine Tumor, Malignant
• Neuroendocrine Tumor Gastrointestinal, Hormone-Secreting

Interventions

• 90Y-DOTA-3-Tyr-Octreotide
• 131I-MIBG

Primary outcomes

• glomular filtration rate (eGFR) — 4 and 8 weeks after each treatment, then at 3, 6, & 9 months after the last treatment
  Evaluate renal toxicity using eGFR measurement
• urine protein — Monthly beginning 4 weeks after the first treatment through 6 months after the last treatment
  Evaluate renal toxicity using urine protein measurement
• platelet count decreased — Weeks 4, 5, 6, 7, 8 after each therapy and then 3, 6, & 12 months after the last treatment
  Evaluate bone marrow toxicity using platelet counts
• absolute neutrophil count decreased — Weeks 4, 5, 6, 7, 8 after each therapy and then 3, 6, & 12 months after the last treatment
  Evaluate bone marrow toxicity using absolute neutrophil count

Countries

United States