High Dose Chemotherapy and Autologous Transplant for Neuroblastoma

NACompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

March 28, 2012

Primary Completion Date

May 30, 2023

Study Completion Date

May 30, 2023

Conditions
Neuroblastoma
Interventions
DRUG

Carboplatin

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.

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 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.

RADIATION

Radiation therapy

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.

DRUG

Isotretinoin (13-cis-retinoic acid)

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.

DRUG

Melphalan

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

DRUG

Etoposide

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

Trial Locations (1)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT01526603 - High Dose Chemotherapy and Autologous Transplant for Neuroblastoma | Biotech Hunter | Biotech Hunter