Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
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ClinicalTrials.gov Identifier: NCT00049023 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 21, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
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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 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | N/A |
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 |
Study Start Date : | January 2002 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
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Experimental: 90Y-DOTA-tyr3-OCTREOTIDE
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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Radiation: 90Y-DOTA-tyr3-OCTREOTIDE |
- 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.

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Ages Eligible for Study: | 2 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed malignant neoplasm
- Not amenable to standard therapy or has failed existing first- and second-line therapies
- Tumor positive for somatostatin receptors by OctreoScan within the past 4 weeks
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At least 1 measurable lesion
- Lesions that have been previously irradiated must demonstrate progression since radiation
- At least 1 measurable somatostatin receptor-positive lesion that has not been irradiated within the past 4 weeks AND has not had full craniospinal radiation within the past 3 months
- 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
- 2 to 25
Performance status
- COG 0-2 OR
- Karnofsky 60-100% OR
- Lansky 60-100%
Life expectancy
- 2-12 months
Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin less than 1.5 times normal
- AST and ALT less than 2.5 times upper limit of normal
Renal
- Creatinine no greater than 1 mg/dL (children less than 5 years of age)
- Creatinine less than 1.2 mg/dL (children 5 to 10 years of age)
- Creatinine less than 1.7 mg/dL (children over 10 years of age) AND
- Glomerular filtration rate at least 80 mL/min/m^2
Cardiovascular
- Shortening fraction at least 28% by echocardiogram
- Ejection fraction at least 50% by bi-plane method of echocardiogram
- No prior congestive heart failure unless ejection fraction at least 40%
- No unstable angina pectoris
- No cardiac arrhythmia
- No symptomatic congestive heart failure
Other
- No other concurrent malignancy
- No other significant uncontrolled medical, psychiatric, or surgical condition that would preclude study compliance
- No antibodies to yttrium Y 90-DOTA-tyr3-octreotide or octreotide
- No prior allergic reactions to compounds of similar chemical or biologic composition to yttrium Y 90-DOTA-tyr3-octreotide
- No ongoing or active infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
- More than 28 days since prior long-acting somatostatin analogues
- No concurrent somatostatin analogues 12 hours before or 12 hours after study drug administration
- Concurrent hormonal therapy (other than somatostatin analogue) allowed provided patient received hormonal therapy for at least 2 months and has stable disease or progressive disease
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to 25% or more of bone marrow
- No prior external beam radiotherapy to both kidneys (scatter doses of less than 500 cGy to a single kidney or radiation to less than 50% of a single kidney is allowed)
Surgery
- At least 4 weeks since prior surgery
Other
- Recovered from prior therapy
- At least 4 weeks since prior investigational drugs
- No other concurrent approved or investigational anti-neoplastic therapies except for bisphosphonates
- No concurrent combination antiretroviral therapy for HIV-positive patients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Responsible Party: | O'Dorisio, M S, Professor, University of Iowa |
ClinicalTrials.gov Identifier: | NCT00049023 |
Other Study ID Numbers: |
200008086 UIHC-200008086 NCI-V02-1710 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | June 21, 2016 |
Last Verified: | June 2016 |
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 |
Neoplasms Sarcoma Neuroblastoma Nervous System Neoplasms Central Nervous System Neoplasms Carcinoid Tumor Pheochromocytoma Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Adenoma, Islet Cell Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Neuroendocrine Tumors Adenocarcinoma Carcinoma Paraganglioma Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Adenoma Pancreatic Neoplasms |