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| ID | Type | Description | Link |
|---|---|---|---|
| UIHC-200008086 | |||
| NCI-V02-1710 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 90Y-DOTA-tyr3-OCTREOTIDE | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 90Y-DOTA-tyr3-OCTREOTIDE | Radiation |
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| Measure | Description | Time Frame |
|---|---|---|
| Establish the three-cycle maximum-tolerated dose of 90Y-DOTA-tyr3-Octreotide | 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. | 6 weeks per cycle |
| Evaluate the short term and long term safety (mild/moderate/severe/life-threatening adverse events, premature discontinuations and serious adverse events) | 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. | short term (6 weeks/cycle); long term (4-6 mos./cycle) |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant neoplasm
Tumor positive for somatostatin receptors by OctreoScan within the past 4 weeks
At least 1 measurable lesion
Bone marrow with at least 40% cellularity OR at least 20% cellularity with one million CD34+ stem cells/kg stored
No diffuse bone marrow involvement by OctreoScan scintigraphy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| M. Sue O'Dorisio, MD, PhD | Holden Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20847174 | Result | Menda Y, O'Dorisio MS, Kao S, Khanna G, Michael S, Connolly M, Babich J, O'Dorisio T, Bushnell D, Madsen M. Phase I trial of 90Y-DOTATOC therapy in children and young adults with refractory solid tumors that express somatostatin receptors. J Nucl Med. 2010 Oct;51(10):1524-31. doi: 10.2967/jnumed.110.075226. Epub 2010 Sep 16. |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D007516 | Adenoma, Islet Cell |
| D009447 | Neuroblastoma |
| D010673 | Pheochromocytoma |
| D012509 | Sarcoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D008527 | Medulloblastoma |
| C531673 | Familial ependymoma |
| D018273 | Carcinoma, Islet Cell |
| D015408 | Gastrinoma |
| D007340 | Insulinoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D010235 | Paraganglioma |
| D018358 | Neuroendocrine Tumors |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D005910 | Glioma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
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