Clinical trial · Interventional
Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
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
NCT00049023CI-TRIAL-00022651completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Islet Cell Tumor | Pancreatic Neuroendocrine Tumor | ALIAS | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Pheochromocytoma | Adrenal Gland Pheochromocytoma | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 90Y-DOTA-tyr3-OCTREOTIDE | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 90Y-DOTA-tyr3-OCTREOTIDE
- description
- 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.
- interventionNames
- Radiation: 90Y-DOTA-tyr3-OCTREOTIDE
Primary outcomes (2)
- measure
- Establish the three-cycle maximum-tolerated dose of 90Y-DOTA-tyr3-Octreotide
- timeFrame
- 6 weeks per cycle
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 25 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * 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 * 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
References
Publications (1)
- RESULTMenda 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. PMID 20847174