Status:
COMPLETED
Iodine I 131 Monoclonal Antibody 3F8 and Bevacizumab in Treating Patients With Relapsed or Refractory Neuroblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neuroblastoma
Eligibility:
All Genders
1+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8 and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Othe...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity of iodine I 131 monoclonal antibody 3F8 (\^131I-3F8) and bevacizumab in patients with relapsed or refractory neuroblastoma. * Determine the hematopoietic...
Eligibility Criteria
Inclusion
- Subject
- Patients must have the diagnosis of NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM involvement plus elevated urinary catecholamines.
- Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy.
- Patients must have evaluable (microscopic marrow metastasis, MIBG or PET scans) or measurable (CT, MRI) disease.
- Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy or radioimmunotherapy.
- Age \>1 year and able to cooperate with radiation safety restrictions during therapy period.
- Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for hematopoietic stem cells is 2 X106 CD34+ cells/kg.
- Minimum life expectancy of four weeks.
- Signed informed consent indicating awareness of the investigational nature of this program.
- Subject
Exclusion
- Severe major organ toxicity. Renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less (per NCI CTC version 3 criteria). Specifically, serum creatinine should be ≤3 x upper limit of normal (ULN), serum AST and ALT ≤5 x ULN, serum bilirubin ≤ 3 x ULN, LV shortening fraction should be ≥15%.
- Patients with myelosuppression are not excluded if ANC ≥ 500/uL. Platelet count should be \> 50,000/ul and hemoglobin should be \> 8gm/dl. Patients may receive platelet or red blood cell transfusions to maintain hemoglobin and platelets at clinical appropriate levels.
- Patients with documented chronic non-healing wound, ulcer or bone fracture
- Surgical procedures.
- Patients who have undergone major surgery \<28 days prior to beginning therapy with bevacizumab are excluded.
- Patients must be least 24 hours from having after surgical procedures such as placement of central catheter.
- Patients \<7days from minor surgeries (e.g. fine needle or core biopsies) and/or the unhealed wounds from these procedures are excluded.
- Patients will be excluded if major surgery (e.g. abdominal or thoracic surgery for resection of tumor) is anticipated during the course of the study.
- Known bleeding diathesis or coagulopathy. Patients on anti-coagulants (except for heparin flushes for centra venous catheter maintenance) are excluded.
- Thrombosis: patients must not have had a deep venous or arterial thrombosis (non-central venous catheter related) within the last three months prior to study entry. Patients with cerebrovascular accident or transient ischemic attack within 6 months of therapy are excluded. Patients with history of peripheral vascular disease, myocardial infarction or unstable angina are excluded.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry.
- Pulmonary or CNS metastases: pre-therapy CT or MRI of head and chest must be carried out.
- Proteinuria: Urine protein: creatinine ratio ≥ 1.0
- Uncontrolled hypertension.
- HAMA \>1000 ELISA units/ml.
- History of allergy to mouse proteins, Chinese hamster ovary cells products or other recombinant human antibodies
- Active serious infections not controlled by antibiotics.
- Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
- Inability or unwillingness to comply with radiation safety procedures or protocol requirements.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00450827
Start Date
August 1 2006
End Date
August 1 2015
Last Update
September 28 2015
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065