Study of Donor Derived, Multi-virus-specific, Cytotoxic T-Lymphocytes for Relapsed/Refractory Neuroblastoma (STALLONe)
|ClinicalTrials.gov Identifier: NCT01460901|
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : February 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Biological: Tri-virus specific cytotoxic t-cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Donor Derived,Gene Modified, Multi-virus-specific, Cytotoxic T-Lymphocytes Redirected to the Tumor Marker GD2 for Relapsed/Refractory Neuroblastoma Post-allogeneic Stem Cell Transplantation With a Submyeloblative Conditioning Regimen|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
- Biological: Tri-virus specific cytotoxic t-cells
Infusion of donor derived tri-virus specific cytotoxic t-cell post allogeneic stem cell transplantation
- Infusional and long term safety and persistence of tumor redirected, genetically modified, donor derived, allogeneic multi-virus specific cytotoxic T-cells (tV-CTL) after allogeneic hematopoietic stem cell transplant in patients with neuroblastoma [ Time Frame: 15 years ]Immediate and short term toxicity of infusion will be assessed over 8 weeks. Yearly monitoring for insertional mutagenesis/oncogenesis will be performed for 15 years.
- Evaluating the survival, expansion, anti-viral and anti-tumor function of infused tV-CTL after allogeneic transplant in patients with neuroblastoma [ Time Frame: 1 year, then yearly for 15 years ]Specimens evaluating survival and expansion will be measured weekly for 8 weeks then at 3, 6, 9 & 12 months, then yearly for 15 years. Viral infections will be monitored and tumor evaluated pre and post-cell infusion and as indicated clinically.
- Comparing the frequency and expansion of allogeneic, tumor redirected, multi-virus cytotoxic T-cells to that of identically transduced, autologous EBV-specific T-cells infused in prior studies. [ Time Frame: 1 year then yearly for 15 years ]Specimens evaluating survival and expansion will be measured weekly for 8 weeks then at 3, 6, 9 & 12 months, then yearly for 15 years. Viral infections will be monitored and tumor evaluated pre and post-cell infusion and as indicated clinically.
- Comparing anti-viral immunity after infusion of gene modified, multi-virus specific T-cells to that of patients receiving viral-specific T-cells without gene modification following allogeneic transplant [ Time Frame: 1 year ]Results of PCR for the gene construct and viral infections over the first year as per primary outcome #2 will be compared to trials of viral specific T-cell infusions in patients following allogeneic transplant on other trials.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460901
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Doug Myers, MD||Children's Mercy Hospital Kansas City|