Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors

Conditions:Cancer, Brain Cancer, Lymphoma
Therapuetic Areas:Oncology
Age Range:2 - 25
Start Date:January 2002

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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

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.


- 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.


- Histologically or cytologically confirmed malignant neoplasm

- Not amenable to standard therapy or has failed existing first- and second-line

- 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

- 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



- 2 to 25

Performance status

- COG 0-2 OR

- Karnofsky 60-100% OR

- Lansky 60-100%

Life expectancy

- 2-12 months


- See Disease Characteristics

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin less than 1.5 times normal

- AST and ALT less than 2.5 times upper limit of normal


- 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


- 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


- 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


Biologic therapy

- Not specified


- 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

- 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


- 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)


- At least 4 weeks since prior surgery


- Recovered from prior therapy

- At least 4 weeks since prior investigational drugs

- No other concurrent approved or investigational anti-neoplastic therapies except for

- No concurrent combination antiretroviral therapy for HIV-positive patients
We found this trial at
200 Hawkins Drive
Iowa City, Iowa 52242
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
Iowa City, IA
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