Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT02605421|
Recruitment Status : Recruiting
First Posted : November 16, 2015
Last Update Posted : November 3, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: Thiotepa Drug: Cyclophosphamide Drug: Melphalan Drug: Etoposide Drug: Carboplatin Biological: Autologous Stem Cell Infusion Biological: Granulocyte colony stimulating factor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
Experimental: Patients Treated for Neuroblastoma
Consolidation course #1 consists of thiotepa and cyclophosphamide followed by a PBSC rescue. Consolidation course #2 consists of melphalan, etoposide and carboplatin followed by a second PBSC rescue. Post infusion, patients will receive Granulocyte-Colony Stimulating Factor beginning on Day 0 of each consolidation course.
Thiotepa by IV once daily for 3 doses on Days -7, -6 and -5. Given as part of Consolidation Course #1 along with Cyclophosphamide.
Cyclophosphamide by IV once daily for 4 doses on Days -5, -4, -3 and -2. Given as part of Consolidation Course #1 along with Thiotepa.
Melphalan by IV once daily for 3 doses on Days -8, -7, and -6. Given as part of Consolidation Course #2 along with Etoposide and Carboplatin.
Etoposide by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Melphalan and Carboplatin.
Carboplatin by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Etoposide and Melphalan.
Biological: Autologous Stem Cell Infusion
On Day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Biological: Granulocyte colony stimulating factor
Beginning on day 0 after infusion of the PBSC, patients will receive G-CSF SQ or IV (SQ preferred) 5 micrograms/kg once daily and continuing once daily until post-nadir ANC > 2000/μL for 3 consecutive days.
Other Name: G-CSF
- Progression Free Survival [ Time Frame: 3 years from first PBSC infusion ]Percentage of patients with progression free survial. Kaplan-Meier curves and 95% confidence intervals will be used to estimate.
- Time to Engraftment [ Time Frame: Day 42 ]Defined as an absolute neutrophil count (ANC) greater than or equal to 0.5 x 109/L for three consecutive days by day 42 after first transplant.
- Relapse [ Time Frame: 3 years from first PBSC infusion ]Percentage of patients with relapse. Relapse will be defined as any new lesion; increase of any measurable lesion by >25%; previous negative bone is positive.
- Overall Survival [ Time Frame: 3 years from first PBSC infusion ]Kaplan-Meier curves and 95% confidence intervals will be used to estimate overall survival.
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|Ages Eligible for Study:||up to 30 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Less than 30 years of age at diagnosis of neuroblastoma
- End of Induction disease evaluation demonstrating CR, PR, MR or SD
- Hematopoietic Recovery from last induction course of chemotherapy
- No uncontrolled infection
- Minimum frozen PBSCs of 2 x 10^6 CD34 cells/kg for each transplant are mandatory and a PBSC of 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of no less than 6 x 10^6 CD34 cells/kg is encouraged). These must all be collected prior to the initiation of consolidation.
Adequate organ function defined as:
- Hepatic: AST and ALT < 3 x upper limit of institutional normal; ALT ≤ 3 x ULN for age; total bilirubin ≤ 1.5 x ULN for age, if baseline was normal, > 1.0 1.5 x baseline if baseline was abnormal
- Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 45%, no clinical congestive heart failure
- Pulmonary: no evidence of dyspnea at rest and norequirement for supplemental oxygen
- Renal: Creatinine clearance or GFR > 60 mL/min/1.73m^2. If a creatinine clearance is performed at end induction and the result is < 100 ml/min/1.73m^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of < 100 ml/min/1.73m^2
- Recovery from acute toxicities of last cycle of induction chemotherapy
- Appropriate written consent - adult or parent/guardian if patient is < 18 years of age and minor information sheet if patient is > 8 years of age
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): NCT02605421
|Contact: Lisa Burke||612-273-8482||lburke3@Fairview.org|
|Contact: Ashish Gupta, MBBS, MPHemail@example.com|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Lisa Burke, RN 612-273-8482 lburke3@Fairview.org|
|Principal Investigator: Ashish Gupta, MBBS, MPH|
|Principal Investigator:||Ashish Gupta, MBBS, MPH||Masonic Cancer Center, University of Minnesota|
|Responsible Party:||Masonic Cancer Center, University of Minnesota|
|Other Study ID Numbers:||
|First Posted:||November 16, 2015 Key Record Dates|
|Last Update Posted:||November 3, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Myeloablative consolidation chemotherapy
Autologous peripheral blood stem cell rescue
Autologous stem cell rescue
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors