Status:
COMPLETED
hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This phase II trial is s...
Detailed Description
OBJECTIVES: * Determine the response rate in children with recurrent or refractory neuroblastoma treated with hu14.18-interleukin-2 (hu14.18-IL2) fusion protein. * Determine the adverse events of thi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed neuroblastoma
- Relapsed or refractory to conventional therapy
- Measurable or evaluable disease documented by 1 of the following criteria:
- Clinical
- Radiographic
- Histologic
- MIBG (meta-iodobenzylguanidine) scanning
- Immunocytochemistry
- No symptomatic pleural effusions or ascites requiring constant or intermittent drainage
- No clinical or radiological evidence of central nervous system (CNS) disease
- PATIENT CHARACTERISTICS:
- Age
- 21 and under
- Performance status
- Karnofsky 50-100% (\> 16 years of age)
- Lansky 50-100% (≤ 16 years of age)
- Life expectancy
- At least 8 weeks
- Hematopoietic
- Absolute neutrophil count \> 1,000/mm\^3
- Platelet count ≥ 75,000/mm\^3\*
- Must not be refractory to platelet transfusions
- Hemoglobin ≥ 9.0 g/dL\* NOTE: \*Transfusion allowed if patient is known to have a history of bone marrow involvement with tumor
- Hepatic
- Alanine transaminase (ALT) \< 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Hepatitis B surface antigen negative
- Renal
- Creatinine adjusted according to age as follows:
- No greater than 0.4 mg/dL (≤ 5 months)
- No greater than 0.5 mg/dL (6 months -11 months)
- No greater than 0.6 mg/dL (1 year-23 months)
- No greater than 0.8 mg/dL (2 years-5 years)
- No greater than 1.0 mg/dL (6 years-9 years)
- No greater than 1.2 mg/dL (10 years-12 years)
- No greater than 1.4 mg/dL (13 years and over \[female\])
- No greater than 1.5 mg/dL (13 years to 15 years \[male\])
- No greater than 1.7 mg/dL (16 years and over \[male\]) OR
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- Cardiovascular
- Shortening fraction ≥ 27% by echocardiogram OR
- Ejection fraction ≥ 50% by Multi Gated Acquisition Scan (MUGA)
- No symptomatic congestive heart failure
- No uncontrolled cardiac rhythm disturbance
- Pulmonary
- Pulse oximetry \> 94% on room air
- Forced vital capacity (FVC) \> 80%
- Forced expiratory volume (FEV\_1) \> 80%
- No abnormal respiratory function
- No dyspnea at rest
- No exercise intolerance
- No prior history of ventilator support related to lung injury (e.g., pneumonia, hemorrhagic pneumonitis, or capillary leakage)
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active uncontrolled infection
- No active uncontrolled peptic ulcer
- No objective peripheral neuropathy ≥ grade 2
- No significant psychiatric disabilities
- No seizure disorders requiring antiseizure medications
- No other concurrent significant illness
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Recovered from prior immunotherapy
- Prior in vivo monoclonal antibodies for biologic therapy or tumor imaging allowed provided there is documented absence of detectable antibody to hu14.18 by serology
- More than 28 days since prior autologous stem cell transplantation
- Prior autologous marrow or stem cell infusion using monoclonal antibody-purged specimens allowed
- More than 1 week since prior growth factors
- At least 7 days since prior nonmyelosuppressive biologic agents
- No prior allogeneic bone marrow or stem cell transplantation
- No concurrent immunomodulating agents
- No concurrent growth factors
- Chemotherapy
- More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No concurrent anticancer chemotherapy
- Endocrine therapy
- No concurrent corticosteroids except 100 mg or less of hydrocortisone (or equivalent) as premedication for blood transfusion or treatment for transfusion reaction
- No other use of systemic steroids
- Radiotherapy
- Recovered from prior radiotherapy
- At least 2 weeks since prior local palliative radiotherapy (small port)
- At least 6 months since prior craniospinal radiotherapy
- At least 6 months since prior total body irradiation
- At least 6 months since prior radiotherapy to ≥ 50% of the pelvis
- At least 6 weeks since other prior substantial bone marrow radiotherapy
- Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable or evaluable lesion is not irradiated
- Surgery
- More than 2 weeks since prior major surgery (e.g., laparotomy or thoracotomy)
- No prior organ allografts
- Other
- No concurrent immunosuppressive drugs
- No other concurrent myelosuppressive antineoplastic drugs
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00082758
Start Date
August 1 2005
End Date
May 1 2012
Last Update
February 12 2015
Active Locations (81)
Enter a location and click search to find clinical trials sorted by distance.
1
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
4
Children's Hospital Central California
Madera, California, United States, 93638-8762