1 |
NCT02868268 |
Recruiting |
Neuroblastoma Precision Trial |
|
- Other: Gene panel sequencing of tumor specimens
|
Observational |
|
- New Approaches to Neuroblastoma Therapy Consortium
- Children's Hospital Los Angeles
- EVAN Foundation
- (and 3 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Identify genomic alterations, whether targetable alterations are present and within 4 defined NBL subgroups or outside of these 4 defined NBL subgroups. Identify presence/absence of immunologic biomarkers common to NBL.
- How many subjects are biopsied or provide available tumor that is found to be adequate for gene panel sequencing and produces a clinical report
- How many patients with bone marrow aspirates performed that contain < 30% tumor cells are able to be enriched and genetic alterations identified
|
90 |
All |
1 Year to 30 Years (Child, Adult) |
NCT02868268 |
N2015-01 |
|
August 2016 |
July 2018 |
December 2018 |
August 16, 2016 |
January 19, 2018 |
|
- Children's Hospital Los Angeles
Los Angeles, California, United States - Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States - UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States - (and 9 more...)
|
2 |
NCT03363373 |
Recruiting |
Naxitamab for Neuroblastoma With Osteomedullary Disease |
|
- Biological: GM-CSF + hu3F8
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate during Naxitamab treatment
- Incidence of adverse events and serious adverse events
- Duration of Response (DoR)
- (and 11 more...)
|
37 |
All |
1 Year and older (Child, Adult, Senior) |
NCT03363373 |
201 |
|
April 2018 |
December 2020 |
December 2023 |
December 6, 2017 |
April 17, 2018 |
|
- Childrens Hospital Los Angeles
Los Angeles, California, United States - University of Florida
Gainesville, Florida, United States - Riley Hospital for Children
Indianapolis, Indiana, United States - (and 6 more...)
|
3 |
NCT02573896 |
Not yet recruiting |
Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells |
|
- Drug: Ch14.18
- Biological: NK Cells
- Drug: Lenalidomide
|
Interventional |
Phase 1 |
- New Approaches to Neuroblastoma Therapy Consortium
- Nationwide Children's Hospital
- United Therapeutics
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Feasibility of expanding NK cells from neuroblastoma patients and cryopreserving, shipping, and infusing multiple doses of NK cells.
- Determination of the Maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of autologous expanded NK cells
- Toxicity (Per Patient)
- Evaluation of Clinical Response (Per Patient)
|
24 |
All |
1 Month to 30 Years (Child, Adult) |
NCT02573896 |
NANT 2013-01 |
|
May 2018 |
October 2020 |
April 2021 |
October 12, 2015 |
April 11, 2018 |
|
- Children's Hospital Los Angeles
Los Angeles, California, United States - Lucille Salter Packer Children's Hospital, Stanford University
Palo Alto, California, United States - UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States - (and 10 more...)
|
4 |
NCT03503864 |
Recruiting New |
Clinical Trial of Arsenic Trioxide Combined Chemotherapy in the Treatment of Stage 4 Neuroblastoma |
|
- Drug: Arsenic Trioxide
- Drug: Conventional induction chemotherapy
|
Interventional |
Phase 2 |
- Yang Li
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Progression free survival
- Incidence of adverse events
|
70 |
All |
up to 14 Years (Child) |
NCT03503864 |
SYSU-81332456 |
|
January 1, 2019 |
December 30, 2029 |
December 30, 2029 |
April 20, 2018 |
April 20, 2018 |
|
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
|
5 |
NCT02615106 |
Recruiting |
Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma |
|
- Drug: Endostar
- Radiation: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor
|
Interventional |
Phase 2 |
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Progression free survival(PFS)
- Overall survival (OS)
- Objective response rate (ORR)
|
60 |
All |
Child, Adult, Senior |
NCT02615106 |
SanghaiXinhua-001 |
|
November 2015 |
November 2017 |
November 2018 |
November 25, 2015 |
June 14, 2016 |
|
- The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China
|
6 |
NCT03294954 |
Not yet recruiting |
GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma |
|
- Genetic: GINAKIT Cells
- Drug: Cyclophosphamide
- Drug: Fludarabine
|
Interventional |
Phase 1 |
- Baylor College of Medicine
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Texas Children's Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with dose limiting toxicity
- Disease free survival
|
24 |
All |
1 Year to 21 Years (Child, Adult) |
NCT03294954 |
GINAKIT2 |
GINAKIT2 |
January 15, 2019 |
February 15, 2020 |
January 15, 2035 |
September 27, 2017 |
October 6, 2017 |
|
- Texas Children's Hospital
Houston, Texas, United States
|
7 |
NCT02641314 |
Recruiting |
Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma |
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- non-inferiority of EFS compared to historical control group
- disease control rate at 6 months
- Overall survival
- (and 5 more...)
|
26 |
All |
2 Years to 20 Years (Child, Adult) |
NCT02641314 |
Uni-Koeln-1495 2011-004593-29 |
METRO-NB2012 |
October 2016 |
October 2018 |
March 2020 |
December 29, 2015 |
October 25, 2016 |
|
- University of Cologne; Dept. Ped. Oncology
Cologne, Germany
|
8 |
NCT02395666 |
Active, not recruiting |
Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission |
|
|
Interventional |
Phase 2 |
- Giselle Sholler
- Beat NB Cancer Foundation
- Because of Ezra
- Spectrum Health Hospitals
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of participants with event free survival (EFS) during study.
- Length of time that participants experience Overall Survival (OS)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- (and 8 more...)
|
142 |
All |
up to 21 Years (Child, Adult) |
NCT02395666 |
NMTRC003B |
|
March 2015 |
March 2018 |
March 2021 |
March 23, 2015 |
April 27, 2017 |
|
- Phoenix Children's Hospital
Phoenix, Arizona, United States - Rady Children's Hospital
San Diego, California, United States - Connecticut Children's Hospital
Hartford, Connecticut, United States - (and 18 more...)
|
9 |
NCT01493830 |
Completed |
Biomarkers in Tumor Samples From Younger Patients With Neuroblastoma |
|
- Genetic: fluorescence in situ hybridization
- Genetic: gene expression analysis
- Genetic: microarray analysis
- (and 5 more...)
|
Observational |
|
- Children's Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- Expression of UBE4B, hrs, and members of the ubiquitination protein complex
- Expression levels and cellular localization of the UBE4B, hrs, and growth factor receptors
- 1p36 deletion status and its association with UBE4B
|
5 |
All |
up to 120 Years (Child, Adult, Senior) |
NCT01493830 |
ANBL12B4 COG-ANBL12B4 NCI-2012-00091 |
|
December 2011 |
July 2016 |
|
December 16, 2011 |
July 11, 2016 |
|
|
10 |
NCT01802138 |
Active, not recruiting |
A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma |
|
- Biological: Activated T lymphocyte
|
Interventional |
Not Applicable |
- Seoul National University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- T cell count after in vitro expansion
- Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria
|
6 |
All |
up to 21 Years (Child, Adult) |
NCT01802138 |
ILC_IIT_03 |
|
February 2013 |
June 2016 |
December 2017 |
March 1, 2013 |
April 28, 2017 |
|
- Seoul National University Hospital
Seoul, Chongno-gu, Korea, Republic of
|
11 |
NCT02743429 |
Recruiting |
Phase II Study of Monoclonal Antibody ch14.18/CHO Continuous Infusion in Patients With Primary Refractory or Relapsed Neuroblastoma |
|
|
Interventional |
Phase 2 |
- University Medicine Greifswald
- Children's Cancer Research Institute, Austria
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Anti-tumour activity of ch14.18/CHO continuous infusion
- Progression-Free Survival
- Safety and tolerability
- (and 12 more...)
|
40 |
All |
1 Year to 21 Years (Child, Adult) |
NCT02743429 |
APN311-304 |
|
March 2015 |
December 2017 |
June 2020 |
April 19, 2016 |
November 9, 2016 |
|
- University Medicine Greifswald
Greifswald, Germany
|
12 |
NCT02075177 |
Available |
Expanded Access Study of Fenretinide Lym-X-Sorb Plus Ketoconazole in Neuroblastoma |
- Recurrent Neuroblastoma
- Neuroblastoma
|
- Drug: Fenretinide Lym-X-Sorb Oral Powder
- Drug: Ketoconazole
|
Expanded Access |
|
- South Plains Oncology Consortium
|
Other |
|
|
|
All |
Child, Adult, Senior |
NCT02075177 |
SPOC-2014-001 |
|
|
|
|
March 3, 2014 |
May 24, 2017 |
|
- University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States - UT Southwestern Medical Center
Dallas, Texas, United States - Cook Children's Hospital
Fort Worth, Texas, United States
|
13 |
NCT00808899 |
Terminated Has Results |
Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma |
|
- Drug: Temsirolimus
- Drug: Irinotecan
- Procedure: Surgical Resection of Primary Tumor
- (and 8 more...)
|
Interventional |
Phase 2 |
- St. Jude Children's Research Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete Response Plus Partial Response
|
4 |
All |
up to 18 Years (Child, Adult) |
NCT00808899 |
NB2008 |
|
December 2008 |
July 2009 |
July 2009 |
December 16, 2008 |
May 30, 2017 |
May 20, 2010 |
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
14 |
NCT01308905 |
Recruiting |
Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET) |
|
|
Interventional |
Not Applicable |
- Barbara Ann Karmanos Cancer Institute
- Children's Hospital of Michigan
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
- To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
- To evaluate the utility of FLT-PET in early assessment of patient response to
|
50 |
All |
up to 21 Years (Child, Adult) |
NCT01308905 |
WSU 2009-031 |
|
February 2011 |
February 2018 |
February 2018 |
March 4, 2011 |
April 6, 2017 |
|
- Children's Hospital of Michigan
Detroit, Michigan, United States
|
15 |
NCT03373097 |
Recruiting |
Anti-GD2 CAR T Cells in Pediatric Patients Affected by High Risk and/or Relapsed/Refractory Neuroblastoma |
- Neuroblastoma
- Neuroblastoma Recurrent
|
|
Interventional |
Phase 1 Phase 2 |
- Bambino Gesù Hospital and Research Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I - Identification of the dose limiting toxicity (DLT)
- Phase II - Antitumor effect
- In vivo persistence/expansion of infused CAR T cell
- (and 6 more...)
|
42 |
All |
12 Months to 18 Years (Child, Adult) |
NCT03373097 |
GD2CAR01 |
|
December 2017 |
December 2024 |
December 2027 |
December 14, 2017 |
December 27, 2017 |
|
- Ospedale Pediatrico Bambino Gesù
Roma, Italy
|
16 |
NCT01586260 |
Active, not recruiting |
Preventative Trial of DFMO in Patients With High Risk Neuroblastoma in Remission |
|
|
Interventional |
Phase 2 |
- Giselle Sholler
- Cancer Prevention Pharmaceuticals, Inc.
- University of Arizona
- (and 4 more...)
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS)
- To evaluate the preventative activity of DFMO as a single agent in patients with neuroblastoma who are in remission based on: Overall Survival (OS)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Biology studies
|
89 |
All |
up to 21 Years (Child, Adult) |
NCT01586260 |
NMTRC 003 |
|
June 2012 |
June 2018 |
June 2020 |
April 26, 2012 |
April 27, 2017 |
|
- Phoenix Children's Hospital
Phoenix, Arizona, United States - Rady Children's Hospital
San Diego, California, United States - Connecticut Children's Hospital
Hartford, Connecticut, United States - (and 15 more...)
|
17 |
NCT01059071 |
Completed Has Results |
Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide |
|
- Drug: DFMO
- Drug: Etoposide
|
Interventional |
Phase 1 |
- Giselle Sholler
- Cancer Prevention Pharmaceuticals, Inc.
- University of Arizona
- (and 2 more...)
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
- Progression Free Survival (PFS)
- Number of Patients With an Overall Response Rate (ORR) of PR or CR
- (and 3 more...)
|
21 |
All |
Child, Adult, Senior |
NCT01059071 |
NMTRC 002 |
|
February 2010 |
October 2014 |
May 2015 |
January 29, 2010 |
October 27, 2016 |
June 20, 2016 |
- Children's Hospital of Orange County
Orange, California, United States - Connecticut Children's Hospital
Hartford, Connecticut, United States - Arnold Palmer Hospital for Children- MD Anderson
Orlando, Florida, United States - (and 4 more...)
|
18 |
NCT03242603 |
Recruiting |
Immunotherapy of Neuroblastoma Patients Using a Combination of Anti-GD2 and NK Cells |
|
- Biological: Anti-GD2 in combination with NK cells
|
Interventional |
Phase 1 Phase 2 |
- National University Hospital, Singapore
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To measure tumor response after infusion of expanded activated haploidentical NK cells with anti-GD2. Response will be assessed as defined by Revised International Neuroblastoma Response Criteria 2017.
- To measure the numbers of infused NK cells in peripheral blood at specific time-points after NK cell infusion
- To measure cytokine levels in plasma at specific time-points after NK cell infusion
|
5 |
All |
6 Months to 25 Years (Child, Adult) |
NCT03242603 |
NKEXPGD2 |
NKEXPGD2 |
October 3, 2017 |
August 15, 2019 |
August 15, 2020 |
August 8, 2017 |
March 30, 2018 |
|
- National University Hospital
Singapore, Singapore
|
19 |
NCT02679144 |
Recruiting |
Neuroblastoma Maintenance Therapy Trial |
|
- Drug: Difluoromethylornithine (DFMO)
|
Interventional |
Phase 2 |
- Giselle Sholler
- KC Pharma
- Beat NB Cancer Foundation
- (and 2 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of participants with event free survival (EFS) during study.
- Length of time that participants experience Overall Survival (OS)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- (and 4 more...)
|
258 |
All |
1 Year to 30 Years (Child, Adult) |
NCT02679144 |
NMTRC014 |
NMTT |
February 2016 |
February 2020 |
February 2025 |
February 10, 2016 |
February 15, 2018 |
|
- University of Alabama, Children's of Alabama
Birmingham, Alabama, United States - Phoenix Children's Hospital
Phoenix, Arizona, United States - Arkansas Children's Hospital
Little Rock, Arkansas, United States - (and 28 more...)
|
20 |
NCT01704716 |
Recruiting |
High Risk Neuroblastoma Study 1.7 of SIOP-Europe (SIOPEN) |
|
- Drug: Vincristine
- Drug: Aldesleukin
- Drug: ch14.18/CHO
- (and 8 more...)
|
Interventional |
Phase 3 |
- St. Anna Kinderkrebsforschung
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Event Free Survival (R1: MAT therapy)
- Event Free Survival (R4: immunotherapy)
- Complete metastatic response (R3: Induction therapy)
- Event free survival (R3: Induction therapy)
|
2700 |
All |
1 Month to 21 Years (Child, Adult) |
NCT01704716 |
HR-NBL-1.7 / SIOPEN |
|
February 2002 |
September 2017 |
September 2017 |
October 11, 2012 |
September 27, 2016 |
|
- Sydney Children's Hospital
Sydney, Australia - St. Anna Kinderspital
Vienna, Austra, Austria - Univ.-Klinik für Kinder- und Jugendheilkunde Graz
Graz, Austria - (and 113 more...)
|
21 |
NCT03042429 |
Completed |
Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients |
|
- Drug: Cycles N8, N5 and N6
- Drug: Cycles N5 and N6
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Event free survival
- Overall survival
- early response
- late response
|
360 |
All |
6 Months to 21 Years (Child, Adult) |
NCT03042429 |
UCologne |
NB2004-HR |
January 1, 2007 |
December 31, 2016 |
December 31, 2016 |
February 3, 2017 |
February 6, 2017 |
|
- University of Cologne
Koln, Germany
|
22 |
NCT02298348 |
Recruiting |
Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma |
|
- Drug: Sorafenib
- Drug: Cyclophosphamide
- Drug: Topotecan
|
Interventional |
Phase 1 |
- New Approaches to Neuroblastoma Therapy Consortium
- University of California, San Francisco
- Children's Hospital Los Angeles
- (and 10 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The maximum tolerated dose of sorafenib given twice each day when given in combination with cyclophosphamide/topotecan for 5 days
- The number and types of toxicities of sorafenib when administered in combination with cyclophosphamide and topotecan.
|
18 |
All |
up to 30 Years (Child, Adult) |
NCT02298348 |
NANT 2013-02 |
N2013-02 |
April 2015 |
June 2018 |
January 2019 |
November 21, 2014 |
January 19, 2018 |
|
- Children's Hospital Los Angeles
Los Angeles, California, United States - Lucille Salter Packer Children's Hospital, Stanford University
Palo Alto, California, United States - UCSF Comprehensive Cancer Center
San Francisco, California, United States - (and 10 more...)
|
23 |
NCT02439788 |
Withdrawn |
3RD GENERATION GD2 SPECIFIC CHIMERIC ANTIGEN RECEPTOR TRANSDUCED AUTOLOGOUS NATURAL KILLER T-CELLS FOR NEUROBLASTOMA |
|
- Drug: cyclophosphamide
- Drug: Fludarabine
- Genetic: GINAKIT Cells
|
Interventional |
Phase 1 |
- Baylor College of Medicine
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Texas Children's Hospital
- Alex's Lemonade Stand Foundation
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients with dose limiting toxicities
- Number of patients with a tumor response
- Number of patients with an immunologic response
|
0 |
All |
1 Year to 18 Years (Child, Adult) |
NCT02439788 |
H-33272, GINAKIT |
GINAKIT |
August 2017 |
September 2019 |
October 2030 |
May 12, 2015 |
June 14, 2017 |
|
- Texas Children's Hospital
Houston, Texas, United States
|
24 |
NCT01156350 |
Unknown † |
Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma |
|
- Drug: Busulfan - Fludarabine - TBI
|
Interventional |
Phase 2 |
- University Hospital, Clermont-Ferrand
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of the feasibility of the CD3 / CD19 selected haplo identical hematopoietic stem cell transplant after conditioning with reduced intensity in children with neuroblastoma in failure of reference treatments
- Study of the overall survival Study of graft versus tumor effect at day + 100
|
10 |
All |
1 Year to 18 Years (Child, Adult) |
NCT01156350 |
CHU-0075 |
Rice NK |
September 2011 |
September 2013 |
September 2014 |
July 2, 2010 |
January 19, 2011 |
|
- CHU Clermont-Ferrand
Clermont-Ferrand, France
|
25 |
NCT01638572 |
Completed |
Exploring the Possibility to Use Glycosyltransferase as a Prognosis Marker of Neuroblastoma |
|
|
Observational |
|
- National Taiwan University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
|
90 |
All |
up to 18 Years (Child, Adult) |
NCT01638572 |
200910002R |
|
January 2010 |
December 2011 |
December 2011 |
July 11, 2012 |
July 11, 2012 |
|
- National Taiwan University Hospital
Taipei, Taiwan
|
26 |
NCT01576692 |
Active, not recruiting |
Combination Chemotherapy, Monoclonal Antibody, and Natural Killer Cells in Treating Young Patients With Recurrent or Refractory Neuroblastoma |
|
- Biological: Humanized anti-GD2 antibody
- Drug: Chemotherapy
- Other: Cytokines
- (and 2 more...)
|
Interventional |
Phase 1 |
- St. Jude Children's Research Hospital
- CURE Childhood Cancer, Inc.
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients experiencing unacceptable toxicity associated with humanized anti-GD2 antibody/chemotherapy (course 1) and anti-GD2 antibody/chemotherapy/NK cells (course 2).
- Response to treatment
- Time to progression.
- (and 2 more...)
|
34 |
All |
up to 21 Years (Child, Adult) |
NCT01576692 |
GD2NK NCI-2012-00495 |
|
April 2012 |
October 2014 |
October 2018 |
April 12, 2012 |
February 20, 2018 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
27 |
NCT00885326 |
Active, not recruiting |
N2007-02:Bevacizumab,Cyclophosphamide,& Zoledronic Acid in Patients W/ Recurrent or Refractory High-Risk Neuroblastoma |
|
- Drug: Bevacizumab
- Drug: cyclophosphamide
- Drug: zoledronic acid
|
Interventional |
Phase 1 |
- New Approaches to Neuroblastoma Therapy Consortium
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determination of toxicities and feasibility of the combination of bolus plus metronomic cyclophosphamide and zoledronic acid with and without bevacizumab when given to children with refractory or recurrent high risk neuroblastoma.
- Evaluation of response within the confines of a phase I study.
- Analysis of Circulating Endothelial Cells, Circulating Factors, Gene expression and Bone Metabolism Studies.
|
36 |
All |
up to 30 Years (Child, Adult) |
NCT00885326 |
CDR0000638257 P01CA081403 |
|
December 2009 |
April 2014 |
November 2018 |
April 21, 2009 |
April 11, 2018 |
|
- Children's Hospital Los Angeles
Los Angeles, California, United States - Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States - UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States - (and 12 more...)
|
28 |
NCT01407731 |
Completed |
Protein Expression in Human Neuroblastoma Tumor Samples |
|
- Genetic: protein expression analysis
- Genetic: western blotting
- Other: laboratory biomarker analysis
|
Observational |
|
- Children's Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- ITSN1 is highly expressed in neuroblastoma tumors and plays an important role in the development/progression of these tumors
|
20 |
All |
Child, Adult, Senior |
NCT01407731 |
ANBL11B4 COG-ANBL11B4 NCI-2011-03799 |
|
July 2011 |
May 2016 |
May 2016 |
August 2, 2011 |
May 17, 2016 |
|
|
29 |
NCT02605421 |
Recruiting |
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma |
|
- Drug: Thiotepa
- Drug: Cyclophosphamide
- Drug: Melphalan
- (and 4 more...)
|
Interventional |
Phase 2 |
- Masonic Cancer Center, University of Minnesota
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival
- Time to Engraftment
- Relapse
- Overall Survival
|
12 |
All |
up to 30 Years (Child, Adult) |
NCT02605421 |
2015LS108 |
|
June 2016 |
January 2020 |
January 2023 |
November 16, 2015 |
December 5, 2017 |
|
- Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
|
30 |
NCT01857934 |
Recruiting |
Therapy for Children With Advanced Stage Neuroblastoma |
|
- Drug: cyclophosphamide
- Drug: topotecan
- Biological: hu14.18K322A
- (and 18 more...)
|
Interventional |
Phase 2 |
- St. Jude Children's Research Hospital
- Cookies for Kids' Cancer
- CURE Childhood Cancer, Inc.
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with complete or partial response
- Event-free survival (EFS)
- Feasibility of delivering hu14.18K322A to 6 cycles of induction therapy
- (and 3 more...)
|
210 |
All |
up to 18 Years (Child, Adult) |
NCT01857934 |
NB2012 NCI-2013-00034 |
|
July 5, 2013 |
January 2021 |
July 2021 |
May 20, 2013 |
December 20, 2017 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
31 |
NCT00793845 |
Active, not recruiting |
Tandem High-dose Chemotherapy and Autologous Stem Cell Rescue in Patients With High-risk Neuroblastoma |
|
- Drug: Cyclophosphamide
- Drug: Etoposide
- Drug: Carboplatin
- (and 3 more...)
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival and event-free survival, short-term and long-term toxicity of tandem high-dose chemotherapy and autologous stem cell transplantation
|
40 |
All |
Child, Adult, Senior |
NCT00793845 |
2008-07-002 |
|
August 2008 |
January 2015 |
January 2018 |
November 19, 2008 |
May 3, 2017 |
|
- Samsung Medical Center
Seoul, Korea, Republic of
|
32 |
NCT00939965 |
Unknown † |
Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma |
|
- Drug: isotretinoin
- Genetic: DNA analysis
- Genetic: polymerase chain reaction
- (and 2 more...)
|
Interventional |
Not Applicable |
- Children's Cancer and Leukaemia Group
- National Cancer Institute (NCI)
|
Other |
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pharmacokinetics of isotretinoin
- Toxicity according to NCI CTCAE v.3
- Clinical response
|
75 |
All |
up to 18 Years (Child, Adult) |
NCT00939965 |
CCLG-PK-2008-03 CDR0000637053 EU-20914 EUDRACT-2008-003606-33 |
|
February 2009 |
|
|
July 15, 2009 |
August 12, 2013 |
|
- Great Ormond Street Hospital for Children
London, England, United Kingdom - University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
Newcastle-Upon-Tyne, England, United Kingdom - Royal Marsden - Surrey
Sutton, England, United Kingdom
|
33 |
NCT01462396 |
Unknown † |
Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using MHC Mismatched Related Donors |
|
- Device: CD34+ cells selected with the Miltenyi Clinimacs machine
|
Interventional |
Phase 1 |
- Children's Mercy Hospital Kansas City
- University of Kansas
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The immediate safety of a fludarabine based reduced intensity conditioning regimen and CD34+ stem cell selected mis-matched, related, allogeneic transplant will be assess in patients with relapsed/refractory neuroblastoma
- 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
|
10 |
All |
6 Months to 17 Years (Child) |
NCT01462396 |
STALLO |
STALLO |
October 2011 |
December 2015 |
December 2015 |
October 31, 2011 |
February 5, 2015 |
|
- Children's Mercy Hospital
Kanas City, Missouri, United States
|
34 |
NCT01121419 |
Completed |
The Role of IMP3 Expression in Patients With Neuroblastoma |
|
|
Observational |
|
- National Taiwan University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
|
|
All |
up to 18 Years (Child, Adult) |
NCT01121419 |
201002039R |
|
January 2008 |
January 2009 |
January 2009 |
May 12, 2010 |
May 21, 2010 |
|
- Wen-Ming Hsu
Taipei, Taiwan
|
35 |
NCT01510600 |
Completed |
Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma |
|
- Genetic: DNA analysis
- Genetic: polymerase chain reaction
- Other: laboratory biomarker analysis
- Other: medical chart review
|
Observational |
|
- Children's Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method
- Frequency and characteristics of ALT in high-risk NB
- C-circle level as a marker of ALT activity in NB
- (and 2 more...)
|
99 |
All |
up to 30 Years (Child, Adult) |
NCT01510600 |
ANBL12B5 COG-ANBL12B5 CDR0000722061 NCI-2012-00109 |
|
January 2012 |
May 2016 |
May 2016 |
January 16, 2012 |
May 19, 2016 |
|
|
36 |
NCT01520233 |
Completed |
Gene Expression in Predicting Outcome in Samples From Patients With High-Risk Neuroblastoma |
|
- Genetic: RNA analysis
- Genetic: gene expression analysis
- Other: laboratory biomarker analysis
|
Observational |
|
- Children's Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Linear correlation between the nCounter™ Analysis System and the expression data obtained in microarray platforms
- nCounter™ Analysis System and microarray platforms equally predictive of outcome in the high-risk group of neuroblastoma patients
|
100 |
All |
Child, Adult, Senior |
NCT01520233 |
ANBL12B2 COG-ANBL12B2 CDR0000723895 NCI-2012-00240 |
|
January 2012 |
May 2016 |
May 2016 |
January 27, 2012 |
May 17, 2016 |
|
|
37 |
NCT01358604 |
Completed |
Biomarkers in Samples From Young Patients With Neuroblastoma |
|
- Genetic: polymerase chain reaction
- Genetic: protein expression analysis
- Genetic: western blotting
- (and 3 more...)
|
Observational |
|
- Children's Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- ROR1 is expressed on the surface of neuroblastoma cells and constitutes a suitable target for mAb therapy
|
20 |
All |
up to 120 Years (Child, Adult, Senior) |
NCT01358604 |
ANBL11B2 COG-ANBL11B2 NCI-2011-02855 |
|
May 2011 |
April 2016 |
April 2016 |
May 23, 2011 |
April 15, 2016 |
|
|
38 |
NCT02998983 |
Recruiting |
Racotumomab in Patients With High-risk Neuroblastoma |
|
|
Interventional |
Phase 2 |
- Laboratorio Elea S.A.C.I.F. y A.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants who elicit an immune response to a one-year immunization schedule of racotumomab in a cohort study of patients with high-risk neuroblastoma.
- Number of participants in whom minimally disseminated disease in the bone marrow decreases or disappears with a one-year immunization schedule of racotumomab compared to baseline values at study entry.
- Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE v4.0 after a one-year immunization schedule of racotumomab when administered alone or together with onco-specific metronomic chemotherapy therapy.
- Pattern of expression of N-Glycolyl-GM3 gangliosides in tumor samples obtained at disease diagnosis and during follow up if available.
|
39 |
All |
1 Year to 12 Years (Child) |
NCT02998983 |
AR-RACO-2-16 |
|
November 2016 |
November 2019 |
June 2020 |
December 21, 2016 |
September 12, 2017 |
|
- Hospital Universitario Austral
Pilar, Buenos Aires, Argentina - Prof. Dr. J. P. Garrahan National Children's Hospital
Buenos Aires, Argentina
|
39 |
NCT01713439 |
Completed |
Allogeneic Neuroblastoma Cells for Relapsed/ Refractory Neuroblastoma, CYCHEALL |
|
- Biological: Injection of allogeneic neuroblastoma cells
|
Interventional |
Phase 1 |
- Baylor College of Medicine
- Texas Children's Hospital
- The Methodist Hospital System
- (and 2 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To assess the safety of up to four subcutaneous (SC) injections of allogeneic neuroblastoma cells which have been genetically modified by measuring adverse events.
- To assess the safety of up to eight (total) injections in patients who have received the first four injections without unacceptable toxicity and have evidence of stable disease or better after receiving these injections by measuring adverse events.
- To determine whether MHC restricted or unrestricted antitumor immune responses are induced by SC injection of modified allogeneic neuroblasts and the cell doses required to produce these effects measured by punch biopsies.
- Assess the antitumor effect by routine clinical response evaluation by imaging.
|
32 |
All |
Child, Adult, Senior |
NCT01713439 |
H-6441 CYCHEALL CYCHEALL |
CYCHEALL |
December 1997 |
January 2001 |
April 2016 |
October 24, 2012 |
June 9, 2016 |
|
- Houston Methodist Hospital
Houston, Texas, United States - Texas Children's Hospital
Houston, Texas, United States
|
40 |
NCT01460901 |
Completed |
Study of Donor Derived, Multi-virus-specific, Cytotoxic T-Lymphocytes for Relapsed/Refractory Neuroblastoma |
|
- Biological: Tri-virus specific cytotoxic t-cells
|
Interventional |
Phase 1 |
- Children's Mercy Hospital Kansas City
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 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
- Evaluating the survival, expansion, anti-viral and anti-tumor function of infused tV-CTL after allogeneic transplant in patients with neuroblastoma
- 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.
- 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
|
5 |
All |
18 Months to 17 Years (Child) |
NCT01460901 |
STALLONe 00038 |
STALLONe |
October 2011 |
January 2015 |
January 2015 |
October 27, 2011 |
February 6, 2015 |
|
- Children's Mercy Hospital
Kansas City, Missouri, United States
|
41 |
NCT01440283 |
Terminated Has Results |
A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) in High Risk Abdominal Neuroblastoma |
|
- Radiation: Intensity Modulated Radiation Therapy (IMRT)
|
Interventional |
Phase 2 |
- St. Jude Children's Research Hospital
- Mayo Clinic
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Who Failed to Reach Local-regional Control
- Pattern of Local-regional Failure.
- Quantify the Range of Organ Movement During the Breathing Phase Measured by 4-dimensional MRI (4DMRI) and 4DCT.
- Quantify (in mm/cm) the Range of Target Movement During the Breathing Phase Measured by 4DMRI and 4DCT.
|
14 |
All |
6 Months to 18 Years (Child, Adult) |
NCT01440283 |
NBIMRT |
|
September 2011 |
March 2015 |
March 2015 |
September 26, 2011 |
March 3, 2016 |
February 4, 2016 |
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
42 |
NCT01986595 |
Unknown † |
A Pilot Study on ALK Gene Mutations in Neuroblastoma |
|
|
Observational |
|
- National Taiwan University Hospital
|
Other |
- Time Perspective: Cross-Sectional
|
- ALK gene mutations of NB in Taiwan
|
100 |
All |
up to 50 Years (Child, Adult) |
NCT01986595 |
201306008RINB |
|
August 2013 |
July 2014 |
July 2014 |
November 18, 2013 |
November 18, 2013 |
|
- National Taiwan University Children Hospital
Taipei, Taiwan
|
43 |
NCT03209869 |
Suspended |
Treatment of Relapsed or Refractory Neuroblastoma With Expanded Haploidentical NK Cells and Hu14.18-IL2 |
|
- Biological: Ex vivo Expanded and Activated Haploidentical Donor NK Cells
- Biological: Hu14.18-IL2
|
Interventional |
Phase 1 |
- University of Wisconsin, Madison
- National Cancer Institute (NCI)
- Solving Kids’ Cancer
- (and 3 more...)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assess safety of EA-NK cells administered to lymphodepleted patients with relapsed or refractory neuroblastoma followed by daily infusions of hu14.18-IL2 for 7 days, defined as any CTCAE (v. 4.03) grade 3 or 4 toxicity with certain pre-defined exceptions
- Anti-tumor effect of treatment; progression free survival
- Anti-tumor effect of treatment; objective response
- (and 6 more...)
|
6 |
All |
7 Months to 21 Years (Child, Adult) |
NCT03209869 |
UW16009 P30CA014520 2016-1195 |
|
March 12, 2018 |
September 1, 2019 |
September 1, 2020 |
July 6, 2017 |
April 17, 2018 |
|
- University of Wisconsin Carbone Cancer Center; UW Hospital and Clinics
Madison, Wisconsin, United States
|
44 |
NCT00793351 |
Completed |
Reduced Intensity Stem Cell Transplantation in Children With Relapsed Neuroblastoma After Autologous Transplantation |
|
- Procedure: Reduced-intensity allogeneic hematopoietic stem cell transplantation
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- tumor response, overall survival, event-free survival
|
25 |
All |
up to 20 Years (Child, Adult) |
NCT00793351 |
2008-08-073 |
|
September 2008 |
November 2013 |
November 2015 |
November 19, 2008 |
October 19, 2016 |
|
- Samsung Medical Center
Seoul, Korea, Republic of
|
45 |
NCT02919046 |
Recruiting |
Study Evaluating the Efficacy and Safety With CAR-T for Relapsed or Refractory Neuroblastoma in Children |
- Relapsed or Refractory Neuroblastoma
|
- Biological: GD2-targeted CAR-T cells
|
Interventional |
Not Applicable |
- Sinobioway Cell Therapy Co., Ltd.
- Nanjing Children's Hospital
- Children's Hospital of Fudan University
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The overall efficiency of patients with neuroblastoma after autologous CAR-T cell therapy
- Progression free survival
- Overall survival
- (and 2 more...)
|
22 |
All |
1 Year to 14 Years (Child) |
NCT02919046 |
WM-CART-07 |
|
September 2016 |
September 2020 |
September 2020 |
September 29, 2016 |
March 14, 2017 |
|
- Nanjing Children's Hospital
Nanjing, Jiangsu, China - Children's Hospital of Fudan University
Shanghai, Shanghai, China
|
46 |
NCT00659984 |
Completed Has Results |
N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma |
|
- Drug: UltratraceTM Iobenguane I 131 Imaging
- Drug: UltratraceTM Iobenguane I 131 Therapy
|
Interventional |
Phase 2 |
- Molecular Insight Pharmaceuticals, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose
- Dose Limiting Toxicities
- Dosimetric Estimation of Radiation Absorbed Doses to Measurable Lesions
- (and 3 more...)
|
15 |
All |
1 Year to 30 Years (Child, Adult) |
NCT00659984 |
CDR0000593357 NANT-2007-01 |
|
June 2008 |
August 2010 |
November 2010 |
April 17, 2008 |
October 4, 2017 |
March 16, 2017 |
- Childrens Hospital Los Angeles
Los Angeles, California, United States - Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States - UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States - (and 5 more...)
|
47 |
NCT01387724 |
Completed |
Biomarkers in Blood and Tissue Samples From Patients With Newly Diagnosed Neuroblastoma |
|
- Genetic: RNA analysis
- Genetic: polymerase chain reaction
- Genetic: protein expression analysis
- (and 7 more...)
|
Observational |
|
- Children's Oncology Group
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Association of high expression of NPY and its Y2/Y5 Rs in NBs with poor outcome of the disease, advanced stage, increased vascularization and other unfavorable prognostic factors, such as TrkB expression and MYCN amplification
- BDNF/TrkB and TrkAIII up-regulate expression of NPY and its Rs
- NPY upregulates expression of the identified proteins in NB and their Rs in endothelial cells (ECs)
- (and 2 more...)
|
300 |
All |
1 Year to 10 Years (Child) |
NCT01387724 |
ANBL11B1 COG-ANBL11B1 NCI-2011-02862 |
|
June 2011 |
May 2016 |
|
July 4, 2011 |
May 18, 2016 |
|
|
48 |
NCT00186849 |
Completed |
Therapy for Children With Advanced Stage High Risk Neuroblastoma |
|
- Drug: Topotecan, Cyclophosphamide, Cisplatin, Doxorubicin, Etoposide, Ifosfamide, Carboplatin
- Procedure: Peripheral Blood Stem Cell Transplant
|
Interventional |
Phase 2 |
- St. Jude Children's Research Hospital
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate
- Feasibility/toxicity of an intensification phase of high-dose chemotherapy with topotecan and cyclophosphamide followed by autologous peripheral blood stem cell transplant
|
30 |
All |
up to 18 Years (Child, Adult) |
NCT00186849 |
NB-97 |
|
October 1997 |
April 2001 |
April 2001 |
September 16, 2005 |
May 20, 2009 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
49 |
NCT00646230 |
Completed |
N2004-03: Intravenous Fenretinide in Treating Young Patients With Recurrent or Resistant Neuroblastoma |
|
- Drug: fenretinide
- Other: high performance liquid chromatography
- Other: pharmacological study
|
Interventional |
Phase 1 |
- Nant Operations Center
- National Cancer Institute (NCI)
- Children's Hospital Los Angeles
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To define the toxicities of intravenous emulsion 4-HPR given on this schedule.
- To determine the maximum tolerated dose of intravenous emulsion 4-HPR given as a continuous intravenous infusion (CIV) for five days (120 hours) every three weeks in children with recurrent and/or resistant neuroblastoma.
- To determine the plasma pharmacokinetics of intravenous emulsion 4-HPR given on this schedule.
- (and 3 more...)
|
17 |
All |
up to 30 Years (Child, Adult) |
NCT00646230 |
CDR0000584267 P01CA081403 N2004-03 |
IV Fenretinide |
December 2006 |
March 2012 |
March 2012 |
March 28, 2008 |
December 22, 2016 |
|
- Childrens Hospital Los Angeles
Los Angeles, California, United States - Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States - UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States - (and 10 more...)
|
50 |
NCT02163356 |
Recruiting |
Fenretinide Lym-X-Sorb + Ketoconazole + Vincristine for Recurrent or Resistant Neuroblastoma |
- Recurrent Neuroblastoma
- Neuroblastoma
|
- Drug: Fenretinide/LXS Oral Powder
- Drug: Ketoconazole
- Drug: Vincristine
|
Interventional |
Phase 1 |
- South Plains Oncology Consortium
- EVAN Foundation
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose
- Side effect profile of drug combination
- Assess plasma pharmacokinetics of fenretinide
- Disease response
|
42 |
All |
up to 30 Years (Child, Adult) |
NCT02163356 |
SPOC-2013-001 |
SPOC2013-001 |
May 2014 |
May 2018 |
May 2018 |
June 13, 2014 |
May 24, 2017 |
|
- The University of Chicago Medicine Comer Children's
Chicago, Illinois, United States - UT Southwestern Medical Center
Dallas, Texas, United States - Cook Children's Hospital
Fort Worth, Texas, United States - Medical College of Wisconsin
Milwaukee, Wisconsin, United States
|