The Foundation Dedicated to Discovering a Cure for Neuroendocrine Cancer

Caring for Carcinoid Foundation

NCT00049023

Trial 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
ID Number: NCT00049023
Status:
Sponsor: government
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.

Phase: I
Principle: M. Sue O'Dorisio, MD, PhD
Conditions: Carcinoid Tumor, Pheochromocytoma
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


Location:

IA

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