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Auto Transplant for High-Risk or Relapsed Brain and Solid Cancers

N/A
Waitlist Available
Led By Ashish Gupta, MBBS, MPH
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmation of germ cell tumor (GCT) histology for Arm C
One or more unfavorable prognostic features for achieving a CR with conventional-dose chemotherapy for Arm C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS tumors.

Who is the study for?
This trial is for patients with high-risk or relapsed solid tumors or CNS (brain and spinal cord) tumors. Participants must have confirmed malignancy, meet specific disease status criteria, be within a certain age and performance range, and have proper organ function. Pregnant or breastfeeding individuals, those with uncontrolled infections or HIV, and patients on conflicting clinical studies are excluded.Check my eligibility
What is being tested?
The trial tests a treatment regimen involving chemotherapy drugs like busulfan, melphalan, thiotepa (for solid tumors), carboplatin (for CNS tumors), followed by autologous stem cell transplant. For some solid tumors, radiation therapy may follow. The process repeats for three cycles in the case of CNS tumors.See study design
What are the potential side effects?
Potential side effects include damage to bone marrow leading to low blood counts; nausea; vomiting; hair loss; mouth sores; risk of infection due to weakened immune system from chemotherapy and stem cell transplant procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed as a germ cell tumor for treatment group C.
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My cancer has features that make it hard to treat with standard chemo.
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My age and physical ability match the study requirements.
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My disease status qualifies me for one of the study arms.
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My condition qualifies for one of the specific study groups.
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My organs are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Disease Free Survival
Transplantation
Treatment-Related Mortality

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm E: NeuroblastomaExperimental Treatment6 Interventions
Mobilization Chemotherapy and PBSC Collection (day -100 to day -30) Pre-Transplant Conditioning Chemotherapy (day -7 to day -0) Day -7: anti-seizure prophylaxis with lorazepam or levetiracetam Day -6 - -3: Busulfan IV q24 hours x 4 doses Day -1: Melphalan 140 mg/m2 IV Day 0: Autologous Hematopoietic Cell Reinfusion
Group II: Arm D: Certain CNS TumorsExperimental Treatment5 Interventions
Mobilization Chemotherapy and PBSC Collection (day -100 to day -30) Pre-Transplant Conditioning Chemotherapy (3 cycles) Day -8, -7, -6: Carboplatin as calculated from AUC of 7 approx. Day -5, -4, -3: Thiotepa 10 mg/kg, Etoposide 8.3 mg/kg Day 0: Autologous Hematopoietic Cell Reinfusion Day +1: Begin G-CSF(filgrastim) 5 mcg/kg
Group III: Arm C: Germ Cell TumorsExperimental Treatment8 Interventions
High-Dose Chemotherapy (3 cycles) Carboplatin AUC=8 & Etoposide 400 mg/m^2 daily, days -4, -3, and -2 every 21 days Autologous Stem Cell Infusion ≥ 3 x 106 CD34+ cells/kg Day 0 Cycles 1, 2 and 3 TI Chemotherapy & PBSC Collection. Paclitaxel 200mg/m^2 IV over 3 hours on Day 1 every 14 days for 2 cycles Ifosfamide 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles Mesna 2000 mg/m^2 on Days 1-3 every 14 days for 2 cycles G-CSF 10 μg/kg sub q daily on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first Leukapheresis starting on approx. day 11 and continued daily until reaching the collection goal of ≥ 8 x 106 CD34+ cells/kg) or day 15, whichever occurs first
Group IV: Arm B: Certain CNS TumorsExperimental Treatment7 Interventions
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, carboplatin (dose based on GFR and age 17 mg/kg/day IV or 510 mg/m^2/day IV) , thiotepa conditioning (10 mg/kg/day or 300 mg/m^2 IV on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0). This will be repeated up to 2 additional 30 day cycles.
Group V: Arm A: Patients with High Risk or Relapsed Solid TumorExperimental Treatment9 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thiotepa
2008
Completed Phase 3
~2150
Autologous stem cell infusion
2009
Completed Phase 1
~90
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440
Busulfan
2008
Completed Phase 3
~1120
G-CSF
2014
Completed Phase 4
~1610
Ifosfamide
2010
Completed Phase 4
~2980
Anti-seizure prophylaxis
2011
N/A
~50
Mesna
2003
Completed Phase 2
~1380
Melphalan
2008
Completed Phase 3
~1500
Paclitaxel
2011
Completed Phase 4
~5380
Radiation
2003
Completed Phase 3
~1020
Leukapheresis
2010
Completed Phase 2
~640
Ursodiol
2006
Completed Phase 4
~400

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
269 Previous Clinical Trials
14,552 Total Patients Enrolled
Ashish Gupta, MBBS, MPHPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
3 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Autologous stem cell infusion Clinical Trial Eligibility Overview. Trial Name: NCT01505569 — N/A
Brain Cancer Research Study Groups: Arm C: Germ Cell Tumors, Arm B: Certain CNS Tumors, Arm A: Patients with High Risk or Relapsed Solid Tumor, Arm D: Certain CNS Tumors, Arm E: Neuroblastoma
Brain Cancer Clinical Trial 2023: Autologous stem cell infusion Highlights & Side Effects. Trial Name: NCT01505569 — N/A
Autologous stem cell infusion 2023 Treatment Timeline for Medical Study. Trial Name: NCT01505569 — N/A
Brain Cancer Patient Testimony for trial: Trial Name: NCT01505569 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what conditions does this remedial measure typically prove efficacious?

"As a first-line treatment for acute lymphoblastic leukemia (ALL), this intervention is also effective at controlling metastatic neoplasms, primary biliary cholangitis and both Hodgkin's and non-Hodgkins' lymphoma."

Answered by AI

Is this clinical endeavor actively soliciting participants now?

"As documented on clinicaltrials.gov, this experiment is currently seeking participants; being initially posted in October 2011 and updated most recently on April 11th 2022."

Answered by AI

How many individuals can register for this trial before it reaches its capacity?

"Affirmative, clinicaltrials.gov showcases that this trial is actively enrolling participants. With its initial posting on October 20th 2011 and most recent edit occurring April 11th 2022, the study requires a total of twenty individuals across one location for completion."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Masonic Cancer Center, University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want to live. I wish to help this study save my life and all lives.
PatientReceived 2+ prior treatments
~3 spots leftby Mar 2025