Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
Condition: Brain and Central Nervous System Tumors; Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Neuroblastoma; Pheochromocytoma; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms; Sarcoma; Neuroblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Carcinoid Tumor; Pheochromocytoma; Malignant Carcinoid Syndrome; Gastrointestinal Neoplasms; Adenoma, Islet Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Radiolabeled octreotide can locate tumor cells and deliver radioactive
      tumor-killing substances to them without harming normal cells.

      PURPOSE: This phase I trial is to study the safety and effectiveness of radiolabeled
      octreotide in treating children who have advanced or refractory solid tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of yttrium Y 90-DOTA-tyr3-octreotide in children
           with advanced or refractory somatostatin receptor-positive tumors.

        -  Determine the short-term and long-term safety and the serious adverse-event profiles of
           this drug in these patients.

        -  Determine any potential antitumor effect of this drug in these patients.

        -  Correlate level of somatostatin receptor type 2 expression with response in patients
           treated with this drug.

      OUTLINE: This is a dose-escalation study.

      Patients receive yttrium Y 90-DOTA-tyr3-octreotide IV over 5-10 minutes on day 1. Treatment
      repeats every 6 weeks for up to 3 courses in the absence of unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of yttrium Y 90-DOTA-tyr3-octreotide until
      the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that
      at which at least 2 of 6 patients experience dose-limiting toxicity.

      Patients are followed weekly after each treatment course, 6 weeks after the last course, and
      then every 6 months thereafter for life.

      PROJECTED ACCRUAL: Approximately 25-35 patients will be accrued for this study.
    

Intervention name(s): 90Y-DOTA-tyr3-OCTREOTIDE
Intervention type(s): Radiation
Intervention MeSH terms: Octreotide; Edotreotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood grade III meningioma; disseminated neuroblastoma; localized unresectable neuroblastoma; metastatic pheochromocytoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent childhood brain tumor; recurrent childhood medulloblastoma; recurrent neuroblastoma; recurrent pheochromocytoma; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; regional neuroblastoma; regional pheochromocytoma; unspecified childhood solid tumor, protocol specific; recurrent childhood ependymoma; childhood infratentorial ependymoma; childhood supratentorial ependymoma; recurrent islet cell carcinoma; gastrinoma; insulinoma; metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; regional gastrointestinal carcinoid tumor