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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

Approved for 20 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years from first pbsc infusion

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival

Secondary study objectives

Overall Survival

Relapse

Time to Engraftment

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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