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Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
Not Recruiting
Trial ID: NCT00054405
Purpose
Phase I trial to compare the effectiveness of interleukin-12 with or without interleukin-2 in
treating young patients who have refractory or recurrent neuroblastoma. Biological therapies
use different ways to stimulate the immune system and stop cancer cells from growing.
Combining interleukin-2 with interleukin-12 may kill more tumor cells.
Official Title
A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)
Eligibility
Inclusion Criteria:
- Diagnosis of neuroblastoma
- Histologically confirmed disease AND/OR disease defined by tumor cells in the
bone marrow and elevated urinary catecholamine metabolites
- Persistent and/or refractory disease, with at least 1 of the following:
- Biopsy-proven residual disease at least 12 weeks after myeloablative therapy
- Progressive disease after nonmyeloablative or myeloablative therapy
- Recurrent disease, evidenced by any of the following:
- Biopsy-proven recurrent soft tissue disease
- Metaiodobenzylguanidine (MIBG)-positive lesions visible on any other imaging
modality or repeat MIBG obtained 2-4 weeks or more apart
- Histologically confirmed bone marrow disease
- Progressive or stable disease after at least 1 prior standard salvage regime
- No clinically significant pleural effusion
- ECOG 0-1
- Life expectancy >= 12 weeks
- Hepatitis A antibody negative
- Hepatitis B surface antigen negative
- Positive hepatitis B titer allowed if patient has been immunized and has no
history of disease
- Hepatitis C virus negative
- No history of congenital or acquired coagulation disorder
- Cardiac function normal by ECG
- No dyspnea at rest
- No exercise intolerance
- Oxygen saturation at least 94% by pulse oximetry
- DLCO greater than 60% of predicted
- FEV1 greater than 70% of predicted
- Negative pregnancy test
- Skull-based bony lesions without space-occupying intracranial extension are allowed
- No prior or concurrent intracranial metastatic disease to the brain parenchyma
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for at least 2
months after study
- No prior hematologic malignancy (including leukemia or lymphoma)
- No history of malignant hyperthermia
- No prior or concurrent autoimmune disease
- No positive direct Coombs testing
- No history of ongoing or intermittent bowel obstruction
- No active infection or other significant systemic illness
- More than 2 weeks since prior fenretinide
- More than 2 weeks since prior 13-cis-retinoic acid
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- More than 2 weeks since prior interferons or interleukins
- More than 2 weeks since prior cytokine-fusion proteins
- More than 2 weeks since prior IV immunoglobulin (IVIG)
- No prior interleukin-12
- No concurrent cytokines
- No concurrent fenretinide
- No concurrent 13-cis-retinoic acid
- No other concurrent immunomodulators, including:
- G-CSF and GM-CSF
- Interferons
- Other interleukins
- IVIG
- More than 4 weeks since prior chemotherapy
- No other unstable medical condition or critical illness that would preclude study
participation
- More than 12 weeks since prior myeloablative chemotherapy followed by autologous stem
cell transplantation:
No prior myeloablative chemotherapy followed by allogeneic bone marrow transplantation
- More than 2 weeks since prior growth hormones
- More than 4 weeks since prior systemic corticosteroids
- More than 2 weeks since prior non-corticosteroid hormonal therapy (including oral
birth control pills)
- No concurrent hormonal therapy (including oral birth control pills)
- No concurrent growth hormones
- No concurrent systemic corticosteroids, except for use in life-threatening
complications
- More than 4 weeks since prior radiotherapy
- No prior solid organ transplantation
- More than 4 weeks since prior investigational agents
- No other concurrent investigational agents
- No prior enrollment on COG-A3973, unless disease has progressed
- No history of hemolytic anemia
- Absolute neutrophil count at least 1,500/mm^3 [Note: Independent of growth factor or
transfusion support]
- Platelet count at least 75,000/mm^3 [Note: Independent of growth factor or transfusion
support]
- AST and ALT less than 2.5 times upper limit of normal
- Bilirubin less than 2.0 mg/dL
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR
creatinine normal
- HIV negative
- Ejection fraction at least 50% by echocardiogram or MUGA OR Fractional shortening at
least 30% by echocardiogram
- No congestive heart failure
- No uncontrolled cardiac arrhythmia
Intervention(s):
biological: aldesleukin
biological: recombinant interleukin-12
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Judy Hallagan
6507248811