Auto Transplant for High Risk or Relapsed Solid Tumor
This is a standard of care treatment guideline for high risk or relapsed solid tumors consisting of a busulfan, melphalan, thiotepa conditioning followed by an autologous peripheral blood stem cell transplant and, if appropriate, disease specific radiation therapy at day +60.
Hematopoietic Stem Cell Transplantation
Drug: Etoposide phosphate
Biological: Granulocyte colony-stimulating factor
Biological: Autologous stem cell infusion
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Alkylator-Intense Conditioning Followed by Autologous Transplantation for Patients With High Risk or Relapsed Solid Tumor|
- Overall Survival [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Number of patients who have received autologous transplant for high risk or relapsed solid tumor and are alive at 1 year.
- Number of Patients Who Achieved Transplant Engraftment [ Time Frame: Day 42 ] [ Designated as safety issue: No ]Engraftment is defined as absolute neutrophil recovery > 500 cells/ul.
- Disease Free Survival [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Number of patients who do not have evidence of disease returning after transplant (alive and in remission).
- Treatment-Related Mortality [ Time Frame: Day 100 ] [ Designated as safety issue: Yes ]Number of patients died due to treatment received.
- Disease Free Survival [ Time Frame: 3 Years ] [ Designated as safety issue: No ]Number of patients who do not have evidence of disease returning after transplant (alive and in remission).
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
Ifosfamide 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
Other Names:Drug: Etoposide phosphate
Etoposide 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.
Other Names:Drug: Mesna
Mesna 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.
Other Names:Biological: Granulocyte colony-stimulating factor
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. All patients should receive 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.
Other Name: G-CSFDrug: Busulfan
Pretransplant conditioning regimen: if <12 kg, 1.1 mg/kg intravenously (IV) every 6 hours,if ≥ 12 kg, 0.8 mg/kg IV every 6 hours on Days 6-8 pretransplant.
Other Name: BusulfexDrug: Melphalan
Pretransplant conditioning regimen: 50 mg/m^2 intravenously (IV) over 30 min on Days 4 and 5 pretransplant.
Other Name: 50 mg/m2 IV over 30 minDrug: Thiotepa
Pretransplant conditioning regimen: 250 mg/m^2 intravenously (IV) over 2 hrs on days 2 and 3 before transplant.
Other Name: ThioplexBiological: Autologous stem cell infusion
On Day 0, stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.Radiation: Radiation
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.
|Contact: Patricia Kleinke, RNemail@example.com|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Michael Verneris, M.D. 612-626-2961 firstname.lastname@example.org|
|Contact: Patricia Kleinke, RN 612-273-2800 email@example.com|
|Principal Investigator: Michael Verneris, M.D.|
|Principal Investigator:||Michael Verneris, M.D.||Masonic Cancer Center, University of Minnesota|