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Topoisomerase Inhibitor

Hematopoietic Cell Transplantation for Atypical Teratoid/Rhabdoid Tumor

Phase 1
Waitlist Available
Led By Kris M Mahadeo, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 100 and 1 year
Awards & highlights

Study Summary

This trial is testing chemotherapy followed by a donor stem cell transplant to treat brain cancer.

Eligible Conditions
  • Atypical Teratoid/Rhabdoid Tumor
  • Neuroectodermal Tumors
  • Brain Cancer
  • Brain Tumor
  • Medulloblastoma
  • Malignant Glioma
  • Anaplastic Ependymoma
  • Primitive Neuroectodermal Tumor
  • Central Nervous System Tumor
  • Choroid Plexus Carcinoma
  • Myeloid Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 100 and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 100 and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of grade III or higher organ toxicity attributable to conditioning
Transplant-related mortality
Secondary outcome measures
Cumulative incidence of relapse
Failure of platelet and neutrophil engraftment rates
Incidence of acute graft-versus-host (GVHD) disease
+7 more

Side effects data

From 2010 Phase 2 trial • 21 Patients • NCT00060424
48%
Neutropenia
10%
Death following disease progression post transplant
10%
Thrombocytopenia
10%
Hyperbilirubinemia
10%
Hypoxia
5%
Typhlitis & Bowel Perforation
5%
Death following progression of GVHD
5%
Cardiac Arrhythmia and Seizure
5%
Death: Sepsis/Renal failure/ with history of GVHD
5%
Severe abnormal pain due to gut GVH
5%
Acute Pulmonary Embolism
5%
Perforated sigmoid diverticulitis
5%
Minimal hydronephosis
5%
Cholecystectomy
5%
Hypotension
5%
Increased creatinine
5%
Neurotoxicity
5%
Renal failure
5%
Tumor lysis syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, HCT)Experimental Treatment8 Interventions
Patients receive thiotepa IV over 2-4 hours and etoposide IV over 60 minutes on days -8 to -6, melphalan IV over 20 minutes on days -5 and -4, and fludarabine phosphate IV over 1 hour on days -5 to -3. Patients receiving umbilical cord transplant only also receive lapine T-lymphocyte immune globulin IV over 4-12 hours on days -4 and -3. Patients then undergo HCT on day 0. Patients also receive tacrolimus IV or cyclosporine IV beginning on day -2 to and mycophenolate mofetil PO every 8 hours or IV from days 0-40 and tapered to day 90.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Tromethamine
FDA approved
Mechlorethamine
FDA approved
Fludarabine
FDA approved
Beta-D-Glucose
Not yet FDA approved
Mycophenolate mofetil
FDA approved
Tacrolimus
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,299 Total Patients Enrolled
Kris M Mahadeo, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Kris M MahadeoPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
40 Total Patients Enrolled

Frequently Asked Questions

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

How is Hematopoietic Cell Transplantation employed to assist patients?

"Small cell lung cancer patients may find relief from Hematopoietic Cell Transplantation, a treatment option that is also beneficial for individuals with dermatitis, atopic diseases, leukemia, myelocytic disorders, acute conditions and lymphoma."

Answered by AI

Have any other investigations been made into the efficacy of Hematopoietic Cell Transplantation?

"At the moment, 833 studies regarding Hematopoietic Cell Transplantation are being conducted. 142 of these reside in Phase 3 with 20264 trial sites spread across Philadelphia and its environs."

Answered by AI

Does this clinical study still have open enrollment?

"Affirmative. Recorded on clinicaltrials.gov, this ongoing medical trial first appeared on January 14th 2021 and was recently updated August 17th 2022. This study is looking for 20 patients from a single research centre to take part in the experiment."

Answered by AI

What is the sample size of subjects participating in this clinical trial?

"Correct. Per the information stored on clinicaltrials.gov, this trial is still recruiting patients with a start date of January 14th 2021 and last update occurring August 17th 2022. Presently, 20 people need to be enrolled from one designated medical facility."

Answered by AI

Has the Food and Drug Administration (FDA) stated its stance on Hematopoietic Cell Transplantation?

"Due to its Phase 1 status, there is minimal evidence regarding the safety and efficacy of Hematopoietic Cell Transplantation; thus our team at Power assesses this treatment with a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Chemotherapy and Donor Stem Transplant for the Treatment of Patients With High Grade Brain Cancer
2021. "Chemotherapy and Donor Stem Transplant for the Treatment of Patients With High Grade Brain Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04521946.
~0 spots leftby Apr 2025
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