Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
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.
|Brain and Central Nervous System Tumors Gastrointestinal Carcinoid Tumor Islet Cell Tumor Neuroblastoma Pheochromocytoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific||Radiation: 90Y-DOTA-tyr3-OCTREOTIDE||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I, Open Label, Maximum Tolerated Dose-Finding Study to Evaluate the Safety and Tolerability of 90Y-DOTA-tyr3-Octreotide Administered by Intravenous Infusion to Children With Refractory Somatostatin-Receptor Positive Tumors|
- Establish the three-cycle maximum-tolerated dose of 90Y-DOTA-tyr3-Octreotide [ Time Frame: 6 weeks per cycle ]Establish the three-cycle maximum-tolerated dose of 90Y-DOTA-tyr3-Octreotide administered by intravenous infusion to children with refractory somatostatin-receptor positive tumors based upon the 6 week/cycle dose-limiting-toxicity profile.
- Evaluate the short term and long term safety (mild/moderate/severe/life-threatening adverse events, premature discontinuations and serious adverse events) [ Time Frame: short term (6 weeks/cycle); long term (4-6 mos./cycle) ]2. Evaluate the short-term (6 weeks/cycle) and long term (4-6 months) safety (mild/moderate/severe/life-threatening adverse events, premature discontinuations and serious adverse events) serious adverse event profile of three-cycles of 90Y-DOTA-tyr3-Octreotide administered by intravenous infusion to children with refractory somatostatin-receptor positive tumors.
|Study Start Date:||January 2002|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Dose escalation will proceed so that the single-cycle and three-cycle maximum tolerated doses of 90Y-DOTA-tyr3-Octreotide can be determined. The initial dose of 90Y-DOTA-tyr3-Octreotide to be administered is 30 mCi/m2 in each of three cycles. Dose escalation will proceed in 10 mCi/m2 intervals and will be permitted for the next cohort of subjects pending completion of Cycle 3 by 2 members of the previous cohort with no DLTs. A DLT is defined as a Grade 3 renal toxicity, Grade 4 bone marrow toxicity, or any other Grade 3 toxicity whether or not related to study drug and regardless of duration. Lymphopenia will not be used to define a DLT.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049023
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|Study Chair:||M. Sue O'Dorisio, MD, PhD||Holden Comprehensive Cancer Center|