Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT01404702|
Recruitment Status : Terminated (Accrual slower than anticipated)
First Posted : July 28, 2011
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: Zoledronic Acid Biological: Aldesleukin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma: Assessment of Tolerability and In Vivo Expansion γδ T-Cells|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
U.S. FDA Resources
|Experimental: Zoledronic Acid and Interleukin-2||
Drug: Zoledronic Acid
4 mg/m2/dose given iv on day 0 of every 28 day cycle
Other Name: ZometaBiological: Aldesleukin
Dose Level 1: 3 x 10^6 IU/m2/day given subcutaneously on days 0 through 4 and 14 through 18 every 28 day cycle
Dose Level 2: 6 x 10^6 IU/m2/day given subcutaneously on days 0 through 4 and 14 through 18 every 28 day cycle
- Evaluate the safety and toxicity of zoledronic acid and aldesleukin [ Time Frame: 1.5 years ]The NCI Common Terminology Criteria for AEs will be used for reporting & identification of dose limiting toxicities. DLTs will include any grade 3 non-hematologic toxicity not included here: Gr 3 nausea & vomiting & diarrhea, Gr 3 fever, Gr 3 skin toxicity that remains stable & tolerable, or improves with treatment within 24 hrs, Gr 3 neurotoxicity with subjective findings, Gr 4 hematologic toxicity, which improves to at least Gr 2 or baseline pre-therapy values within one week of completing IL2 infusion, Gr 3 performance that returns to 50 or higher before the start of the next therapy cycle.
- Evaluate the biologic function of autologous expanded/activated gamma delta T cells in neuroblastoma patients receiving therapy with zoledronic acid and aldesleukin [ Time Frame: 3 years ]The ability of gamma-delta T cells derived from patients' peripheral blood to kill NB cells in vitro will be quantified by standard tumor cytotoxicity assays.
- Evaluate immune phenotype of in vivo expanded/activated autologous gamma delta T cells [ Time Frame: 3 years ]Peripheral blood mononuclear cells will be immunophenotyped by standard conjugation of fluorescent monoclonal antibodies in order to quantify and phenotype patient lymphocytes using flow cytometry.
- To document tumor response in patients with measurable disease. [ Time Frame: 3 years ]Tumor response and progression will be assessed and documented utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Determine the ability of in vivo expanded/activated gamma delta T cells to infiltrate neuroblastoma tissue using immunohistochemical techniques when post-therapy specimens are available. [ Time Frame: 3 years ]Patients with known or suspected bone marrow metastasis will undergo bilateral bone marrow biopsies at the beginning and end of the first course of therapy. This tissue will be fixed and processed per protocol (Appendix I) and infiltrating lymphocytes per hpf will be documented under standard microscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404702
|United States, Alabama|
|University of Alabama at Birmingham-Children's of Alabama|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Joseph Pressey, MD||The University of Alabama at Birmingham|