Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid 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 to study the safety and effectiveness of radiolabeled octreotide in treating children who have advanced or refractory solid tumors.

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.

Eligibility 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