TheranosticTrials.org

Clinical Trial · NCT00049023

Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors

Overview

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.

Sponsor

University of Iowa

Phase

Phase 1

Contacts

M. Sue O'Dorisio, MD, PhD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00049023

Drug / Compound

DOTA-tyr3-octreotide

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • 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
  • 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
  • More than 28 days since prior long-acting somatostatin analogues
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)Endocrine therapy
  • Lesions that have been previously irradiated must demonstrate progression since radiation
  • Negative pregnancy test
  • Absolute neutrophil count at least 1,000/mm\^3
  • Recovered from prior therapy
  • Karnofsky 60-100% OR
  • Bilirubin less than 1.5 times normal
  • Shortening fraction at least 28% by echocardiogram
  • AST and ALT less than 2.5 times upper limit of normalRenal
  • Histologically or cytologically confirmed malignant neoplasm
  • Concurrent hormonal therapy (other than somatostatin analogue) allowed provided patient received hormonal therapy for at least 2 months and has stable disease or progressive diseaseRadiotherapy
  • Lansky 60-100%Life expectancy
  • Platelet count at least 100,000/mm\^3Hepatic
  • COG 0-2 OR
  • 2 to 25Performance status
  • At least 4 weeks since prior investigational drugs
  • Tumor positive for somatostatin receptors by OctreoScan within the past 4 weeks
  • At least 4 weeks since prior radiotherapy
  • Fertile patients must use effective contraception during and for 6 months after study participationBiologic therapy
  • 2-12 monthsHematopoietic
  • Glomerular filtration rate at least 80 mL/min/m\^2Cardiovascular
  • At least 4 weeks since prior surgeryOther
  • Ejection fraction at least 50% by bi-plane method of echocardiogram

Exclusion

  • No symptomatic congestive heart failureOther
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No cardiac arrhythmia
  • No concurrent somatostatin analogues 12 hours before or 12 hours after study drug administration
  • No other concurrent malignancy
  • Not pregnant or nursing
  • Not amenable to standard therapy or has failed existing first- and second-line therapies
  • No prior allergic reactions to compounds of similar chemical or biologic composition to yttrium Y 90-DOTA-tyr3-octreotide
  • No antibodies to yttrium Y 90-DOTA-tyr3-octreotide or octreotide
  • No other concurrent approved or investigational anti-neoplastic therapies except for bisphosphonates
  • No prior radiotherapy to 25% or more of bone marrow
  • No ongoing or active infection
  • 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
  • No unstable angina pectoris
  • Not specifiedChemotherapy
  • No prior congestive heart failure unless ejection fraction at least 40%
  • No other significant uncontrolled medical, psychiatric, or surgical condition that would preclude study compliance