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Alkylating agents

Chemotherapy + Stem Cell Rescue for Neuroblastoma

Phase 2
Recruiting
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
Adequate organ function defined as: Hepatic: AST and ALT < 3 x upper limit of institutional normal; ALT ≤ 3 x ULN for age; total bilirubin ≤ 1.5 x ULN for age, if baseline was normal, > 1.0 1.5 x baseline if baseline was abnormal; Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 45%, no clinical congestive heart failure; Pulmonary: no evidence of dyspnea at rest and no requirement for supplemental oxygen; Renal: Creatinine clearance or GFR > 60 mL/min/1.73m^2. If a creatinine clearance is performed at end induction and the result is < 100 ml/min/1.73m^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of < 100 ml/min/1.73m^2; Recovery from acute toxicities of last cycle of induction chemotherapy; Appropriate written consent - adult or parent/guardian if patient is < 18 years of age and minor information sheet if patient is > 8 years of age
No uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years from first pbsc infusion
Awards & highlights

Study Summary

This trial is testing a new treatment for neuroblastoma that involves two courses of chemotherapy followed by stem cell rescue.

Who is the study for?
This trial is for patients under 30 years old with high-risk neuroblastoma who've finished induction chemotherapy. They should show some response to treatment, have no uncontrolled infections, and enough harvested stem cells for transplants. Participants need good liver, heart, lung, and kidney function and must provide consent.Check my eligibility
What is being tested?
The study tests a two-course myeloablative consolidation therapy followed by autologous stem cell rescue in high-risk neuroblastoma patients post-induction chemotherapy. Drugs used include Carboplatin, Thiotepa, Cyclophosphamide, Melphalan, Etoposide along with stem cell infusion and growth factor support.See study design
What are the potential side effects?
Potential side effects may include damage to bone marrow (myelosuppression), increased risk of infection due to low white blood cell counts (neutropenia), nausea or vomiting from the chemotherapy drugs used in the treatment regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any infections that aren't responding to treatment.
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I was diagnosed with neuroblastoma before turning 30.
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My cancer responded to initial treatment or remained stable.
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I have enough stem cells collected for my treatment and backup.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Overall Survival
Relapse
Time to Engraftment

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients Treated for NeuroblastomaExperimental Treatment7 Interventions
Consolidation course #1 consists of thiotepa and cyclophosphamide followed by a PBSC rescue. Consolidation course #2 consists of melphalan, etoposide and carboplatin followed by a second PBSC rescue. Post infusion, patients will receive Granulocyte-Colony Stimulating Factor beginning on Day 0 of each consolidation course.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Filgrastim
FDA approved
Thiotepa
FDA approved
Cyclophosphamide
FDA approved
Melphalan
FDA approved
Etoposide
FDA approved

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
270 Previous Clinical Trials
14,580 Total Patients Enrolled
4 Trials studying Neuroblastoma
130 Patients Enrolled for Neuroblastoma
Ashish Gupta, MBBS, MPHPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
3 Previous Clinical Trials
82 Total Patients Enrolled
1 Trials studying Neuroblastoma
13 Patients Enrolled for Neuroblastoma

Frequently Asked Questions

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

Is Autologous Stem Cell Infusion a novel approach to therapy and has it been tested before?

"Currently, the active number of investigational trials for Autologous Stem Cell Infusion is a robust 1653 with 388 in Phase 3. Leesburg Virginia has an especially high concentration of clinical studies regarding this therapy; however there are roughly 71730 sites participating globally."

Answered by AI

How numerous is the collective of participants involved in this research?

"Indeed, the details located on clinicaltrials.gov confirm that this medical study is currently seeking participants. The research was first announced on June 1st 2016 and has been updated as recently as November 2nd 2022. 12 people need to be recruited from a single clinic for the trial to move forward."

Answered by AI

Has Autologous Stem Cell Infusion attained governmental endorsement?

"Autologous Stem Cell Infusion has been assigned a score of 2 on our power scale, due to the limited data regarding its efficacy as it is only in Phase 2 clinical trials. That said, there have been some studies that demonstrate safety when using this medication."

Answered by AI

What health benefits are typically associated with Autologous Stem Cell Infusion?

"Autologous Stem Cell Infusion is the primary treatment for those suffering from Merkel cell cancer; however, it has also been successfully used to treat leukemia, initial treatments and prostate cancer."

Answered by AI

Are there any vacancies for participants in this trial?

"Affirmative, clinicaltrials.gov offers evidence that this study is accepting participants. Initially posted on June 1st 2016 and recently updated November 2nd 2022, the trial intends to recruit 12 individuals from a single site."

Answered by AI
~0 spots leftby Jul 2024