Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	2 to 25	NCI	UIHC-200008086 NCI-V02-1710, NCT00049023, 200008086

Objectives

1. Determine the maximum tolerated dose of yttrium Y 90-DOTA-tyr3-octreotide in children with advanced or refractory somatostatin receptor-positive tumors.
2. Determine the short-term and long-term safety and the serious adverse-event profiles of this drug in these patients.
3. Determine any potential antitumor effect of this drug in these patients.
4. Correlate level of somatostatin receptor type 2 expression with response in patients treated with this drug.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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/m²

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

Expected Enrollment

Approximately 25-35 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Holden Comprehensive Cancer Center at University of Iowa

M. Sue O'Dorisio, MD, PhD, Protocol chair		Ph: 319-356-7873 Email: sue-odorisio@uiowa.edu

U.S.A.
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225

Registry Information
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
Trial Start Date		2002-01-04
Registered in ClinicalTrials.gov		NCT00049023
Date Submitted to PDQ		2002-08-20
Information Last Verified		2008-04-20
NCI Grant/Contract Number		R21-CA91578, P30-CA86862

Back to Top