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NCT00049023
Trial Title: Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
ID Number: NCT00049023
Status: Not Recruiting
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
- 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
- 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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