Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
Brain and Central Nervous System Tumors, Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring childhood grade III meningioma, disseminated neuroblastoma, localized unresectable neuroblastoma, metastatic pheochromocytoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood brain tumor, recurrent childhood medulloblastoma, recurrent neuroblastoma, recurrent pheochromocytoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, regional neuroblastoma, regional pheochromocytoma, unspecified childhood solid tumor, protocol specific, recurrent childhood ependymoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent islet cell carcinoma, gastrinoma, insulinoma, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor
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
Sites / Locations
- Holden Comprehensive Cancer Center at University of Iowa
Arms of the Study
Arm 1
Experimental
90Y-DOTA-tyr3-OCTREOTIDE
Dose escalation will proceed so that the single-cycle and three-cycle maximum tolerated doses of 90Y-DOTA-tyr3-Octreotide can be determined. The initial dose of 90Y-DOTA-tyr3-Octreotide to be administered is 30 mCi/m2 in each of three cycles. Dose escalation will proceed in 10 mCi/m2 intervals and will be permitted for the next cohort of subjects pending completion of Cycle 3 by 2 members of the previous cohort with no DLTs. A DLT is defined as a Grade 3 renal toxicity, Grade 4 bone marrow toxicity, or any other Grade 3 toxicity whether or not related to study drug and regardless of duration. Lymphopenia will not be used to define a DLT.