Expired Study
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Iowa City, Iowa 52242


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.


Study summary:

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.


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


NCT ID:

NCT00049023


Primary Contact:

Study Chair
M. Sue O'Dorisio, MD, PhD
Holden Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Iowa City, Iowa 52242
United States

Cancer Information Service
Phone: 800-237-1225

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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