An interventional study of Carboplatin and Autologous stem cell infusion in Neuroblastoma, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Masonic Cancer Center, University of Minnesota · Not applicable, Interventional, and Other
This is a standard of care document, outlining the therapy for children with high risk neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.
This therapy involves the use of melphalan, etoposide, and carboplatin (consolidation chemotherapy); autologous stem cell rescue, post-transplant radiation therapy and a maintenance phase with Isotretinoin (Accutane, 13-cis-retinoic acid) therapy. If available, patients should also consider post-transplant therapy with cytokines and monoclonal antibody (ch14.18) on a COG or New Approaches to Neuroblastoma Therapy (NANT) trial.
625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.
This study's enrollment of 13 is below the median of 32 across 475 interventional studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate organ function defined as:
Exclusion Criteria
According to patient weight and renal function, consolidation chemotherapy using various doses of Melphalan, Etoposide, and Carboplatin followed by autologous stem cell infusion and serial post-transplant Granulocyte Colony Stimulating Factor, radiation therapy and Isotretinoin maintenance therapy.
Drug: Carboplatin · Biological: Autologous stem cell infusion · Biological: Granulocyte colony stimulating factor · Radiation: Radiation therapy · Drug: Isotretinoin (13-cis-retinoic acid) · Drug: Melphalan · Drug: Etoposide
Carboplatin intravenously (IV), 425 mg/m2/dose (or if ≤ 12kg, 14.2 mg/kg/dose) once daily x 4 doses on days 7 through 4 pretransplant.
Also known as: Paraplatin
On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Beginning on day 0 after infusion of the PBSC, patients will receive G-CSF subcutaneously (SQ) or IV (SQ preferred) 5 micrograms/kg once daily and continuing once daily until post-nadir absolute neutrophil count (ANC) \> 2000/μL for 3 consecutive days.
Also known as: G-CSF
It is suggested that patients who have a complete surgical resection of the primary tumor receive 21.6 Gy external beam radiation therapy (EBRT) to the post-induction chemotherapy, pre-operative primary tumor volume. It is suggested that patients who have an incomplete surgical resection of the primary tumor (residual soft tissue mass measuring \>1 cm3) will receive 21.6 Gy EBRT to the postinduction chemotherapy, pre-operative primary tumor volume and an additional boost of 14.4 Gy EBRT to the gross residual tumor (total dose 36 Gy to gross residual tumor volume). Radiation should be given after stem cell transplantation and should start no sooner than 28 days post transplant.
Post-transplant maintenance therapy with cis-RA daily for 14 days every 28 days repeated for 6 months. This phase of the therapy can be initiated by the BMT team and continued by the referring physician. It is recommended to begin Isotretinoin at day 66 post-transplant and no later than day 100. For patients ≤12 kg, isotretinoin (accutane) should be administered at 5.33 mg/kg/dose divided twice daily. For patients \>12 kg isotretinoin (accutane) should be administered at 160 mg/m\^2/day divided twice a day. Patients should be considered for monoclonal antibody therapy against GD2, such as ch14.18 if such trials are available.
Also known as: Accutane
Melphalan Intravenously (IV), 70 mg/m2/dose (or if ≤ 12 kg, 2.3 mg/kg/dose) once daily x 3 doses on days 7 through 5 pretransplant
Also known as: Alkeran
Etoposide intravenously (IV), 338 mg/m2/dose (or if ≤ 12kg, 11.3 mg/kg/dose) once daily x 4 doses on days 7 through 4 pretransplant
Also known as: Eposin, VP-16
Number of Patients with Successful Engraftment
The time to neutrophil engraftment will be assessed by standard statistical approaches.
Time frame: Day 42
Number of Patients with Disease Free Survival
The number of patients alive and disease free will be assessed using standard statistical approaches.
Time frame: 2 Years
Overall Survival
The number of patients alive will be assessed by standard statistical approaches.
Time frame: 2 Years
Number of Patients with Treatment Related Death
The rate of treatment related mortality will be assessed by cumulative incidence approach.
Time frame: 1 Year
Number of Patients with Disease Free Survival
The number of patients alive and disease free will be assessed using standard statistical approaches.
Time frame: 5 Years
Overall Survival
The number of patients alive will be assessed by standard statistical approaches.
Time frame: 5 Years
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Masonic Cancer Center, University of Minnesota