Trials / Completed

CompletedNCT01505569

Auto Transplant for High Risk or Relapsed Solid or CNS Tumors

Alkylator-Intense Conditioning Followed by Autologous Transplantation for Patients With High Risk or Relapsed Solid or CNS Tumors

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 44 (actual)

Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
Sex: All
Age: 70 Years
Healthy volunteers: Not accepted

Summary

This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood stem cell transplant will be given for 3 cycles.

Conditions

Interventions

Type	Name	Description
DRUG	Ifosfamide	* Arms A\&B: 1.8 g/m\^2/day intravenously (IV) over 1 hour; given in a window of 30-100 days before transplant for 5 days before conditioning regimen * Arm C: 2000 mg/m\^2 IV daily on Days 1-3 every 14 days for 2 cycles
DRUG	Etoposide	* Arms A\&B: 100 mg/m\^2/day intravenously (IV) over 1 hour; given in a window of 30-100 days before transplant for 5 days prior to conditioning regimen. * Arm C: 400 mg/m\^2 daily on days -4, -3, and -2 every 21 days * Arm D: Etoposide 8.3 mg/kg (or 250mg/m² if age \>36 mos.) approx. hour 75 on days -5, -4, and -3
DRUG	Mesna	* Arms A\&B: 1.8 g/m\^2/day divided in every 6 hrs dosing; given in a window of 30-100 days before transplant for 5 days prior to conditioning regimen. * Arm C: 2000 mg/m\^2 IV daily on Days 1-3 every 14 days for 2 cycles
BIOLOGICAL	G-CSF	* Arms A\&B: Beginning 24 hours after treatment with ifosfamide, etoposide and mesna, administer 10 mcg/kg/day subcutaneously (SQ) or intravenously (IV) until absolute neutrophil count (ANC) is greater than (\>) 1,000/mm\^2. Starting that day, increase dose to 15 mcg/kg/day SQ or IV given as a single injection for 3 doses. G-CSF, 5 ug/kg/day IV as a bolus injection each evening beginning on day 0 until the ANC is \>2500 x 10\^9/L for 2 consecutive days. G-CSF will subsequently be restarted at 5 ug/kg/day SC or IV if the ANC falls below 1000/mm\^3 * Arm C: 10 μg/kg SQ daily beginning 6 hours after ifosfamide on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first. * Arm D: Beginning day +1 following hematopoietic cell reinfusion, patients receive filgrastim at a dose of 5mcg/kg SQ once daily (or 5mcg/Kg IV either daily or twice daily, per institutional preference) * Arm E: 5 micrograms/kg/dose beginning on Day 0 and continue per institutional preference
DRUG	Busulfan	Arm A: 1.1 mg/kg IV every 6 hours on days -8 through -6 Arm E: first dose of busulfan is dosed by mg/kg as appropriate for age and weight. Once the results of pharmacokinetic (PK) studies are known, subsequent daily doses are based upon those results,
DRUG	Melphalan	Arm A: 50 mg/m\^2 intravenously (IV) over 30 min on Days -4 and -5 Arm E:140 mg/m2 AT LEAST 24 hrs after last busulfan dose. Day: -1
DRUG	Thiotepa	Arm A: 250 mg/m\^2 intravenously (IV) over 2 hrs on days -2 and -3 Arm B: 10 mg/kg/day or 300 mg/m\^2 IV on days -3 and -2 Arm D: Thiotepa 10 mg/kg (or 300mg/m² if age \>36 mos.) approx. hour 72 on days -5, -4, and -3
BIOLOGICAL	Autologous stem cell infusion	Arms A, B \& C: On Day 0, stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines. Arm D: On day 0, peripheral blood hematopoietic progenitor cells (PHPCs) or bone marrow cells will be thawed and re-infused about 72 hours following completion of the last dose of chemotherapy. Arm E: stem cells will be infused on Day 0 of Consolidation. Where the DMSO volume in the stem cell product would exceed accepted level for infusion within a 24 hour period, stem cell products may be infused over 2 days to meet this standard.
RADIATION	Radiation	Arm A: If a patient is considered for post-transplant irradiation, a disease appropriate full tumor restaging should be done prior to starting. Whole lung irradiation (1500cGy in 10 fractions) may be given in patients with prior lung metastasis. Areas of known metastatic disease or PET areas may receive "spot" irradiation using a dose and method determined to be tolerable by radiation oncology staff. Additional radiation will be given if primary disease has not been irradiated to maximum tolerated dose.
DRUG	Carboplatin	Arm B: depending on age and GFR 17mg/kg/day IV over 4 hours or 510 mg/m\^2/day IV over 4 hours Arm C: AUC=8 daily on days -4, -3, and -2 every 21 days Arm D: as calculated from AUC of 7 approx. hour 0 on days -8, -7, and -6
DRUG	Paclitaxel	Arm C: 200 mg/m2 IV over 3 hours on Day 1 every 14 days for 2 cycles
PROCEDURE	Leukapheresis	Arm C: Blood will be taken by a needle placed in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out in the machine for purposes of this research and the rest of the blood will be returned through a needle in the other arm.
DRUG	Anti-seizure prophylaxis	Arm E: Lorazepam OR Levetaracetam * Lorazepam should be given 0.02-0.05 mg/kg/dose, given 30 minutes prior to each busulfan dose and then continuing every 6 hours, maximum dose: 2 mg. * Levetiracetam should be given 10 mg/kg/dose PO, administered BID, staring 12 hours prior to busulfan, maximum single dose: 1000mg.
DRUG	Ursodiol	Arm E: 150 mg/m2/dose PO, administered BID, beginning on Day -7 and continuing a minimum of 28 days post-transplant, or until the end of Consolidation.

Timeline

Start date: 2011-10-20
Primary completion: 2024-02-01
Completion: 2024-02-01
First posted: 2012-01-06
Last updated: 2024-02-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01505569. Inclusion in this directory is not an endorsement.