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Sponsors and Collaborators: |
Holden Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049023 |
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 studying the effectiveness of radiolabeled octreotide in treating children who have advanced or refractory solid tumors.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Gastrointestinal Carcinoid Tumor Islet Cell Tumor Neuroblastoma Pheochromocytoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: yttrium Y 90-edotreotide |
Phase I |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 35 |
Study Start Date: | January 2002 |
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.
Ages Eligible for Study: | 2 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant neoplasm
At least 1 measurable lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242-1002 | |
Contact: Cancer Information Service 800-237-1225 |
Study Chair: | M. Sue O'Dorisio, MD, PhD | Holden Comprehensive Cancer Center |
Study ID Numbers: | CDR0000257582, UIHC-200008086, NCI-V02-1710 |
Study First Received: | November 12, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00049023 |
Health Authority: | Unspecified |
gastrinoma 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 insulinoma metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor |
Neuroectodermal Tumors, Primitive Pancreatic Neoplasms Malignant mesenchymal tumor Octreotide Central Nervous System Neoplasms Neoplasms, Connective and Soft Tissue Ewing's sarcoma Neuroepithelioma Nervous System Neoplasms Endocrine Gland Neoplasms Digestive System Neoplasms Carcinoma, Islet Cell Insulinoma Endocrine System Diseases Adenoma, Islet Cell |
Malignant Carcinoid Syndrome Carcinoma Brain Neoplasms Neuroectodermal Tumors Gastrinoma Sarcoma Gastrointestinal Neoplasms Pancreatic Diseases Carcinoid Tumor Neoplasms, Glandular and Epithelial Gastrointestinal Diseases Ewing's family of tumors Ependymoma Neuroblastoma Pheochromocytoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Neoplasms, Nerve Tissue Gastrointestinal Agents Neoplasms, Neuroepithelial Pharmacologic Actions |