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Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
First Received: November 12, 2002   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049023
  Purpose

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
Radiation: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 35
Study Start Date: January 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049023

Locations
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        
Sponsors and Collaborators
Holden Comprehensive Cancer Center
Investigators
Study Chair: M. Sue O'Dorisio, MD, PhD Holden Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000257582, UIHC-200008086, NCI-V02-1710
Study First Received: November 12, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00049023     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Pancreatic Neoplasms
Octreotide
Central Nervous System Neoplasms
Neoplasms, Connective and Soft Tissue
Zollinger-Ellison Syndrome
Neuroepithelioma
Nervous System Neoplasms
Endocrine Gland Neoplasms
Carcinoid Syndrome
Digestive System Neoplasms
Antineoplastic Agents, Hormonal
Carcinoma, Islet Cell
Insulinoma
Endocrine System Diseases
Adenoma, Islet Cell
Malignant Carcinoid Syndrome
Ewing's Sarcoma
Carcinoma
Brain Neoplasms
Neuroectodermal Tumors
Malignant Mesenchymal Tumor
Gastrinoma
Sarcoma
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoid Tumor
Neoplasms, Glandular and Epithelial
Gastrointestinal Diseases
Neuroblastoma

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive
Antineoplastic Agents
Gastrointestinal Diseases
Pancreatic Neoplasms
Neoplasms, Nerve Tissue
Octreotide
Central Nervous System Neoplasms
Pheochromocytoma
Neuroblastoma
Neoplasms, Connective and Soft Tissue
Paraganglioma
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Antineoplastic Agents, Hormonal
Nervous System Diseases
Gastrointestinal Agents
Endocrine System Diseases
Adenoma, Islet Cell
Malignant Carcinoid Syndrome
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Neoplasms
Digestive System Diseases

ClinicalTrials.gov processed this record on July 02, 2009