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Alkylating agent

Sorafenib + Cyclophosphamide/Topotecan for Neuroblastoma (N2013-02 Trial)

Phase 1
Waitlist Available
Research Sponsored by New Approaches to Neuroblastoma Therapy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must not be receiving active anti-coagulation therapy at the time of study entry (or while on study)
Age-adjusted serum creatinine 1.5 x normal for age/gender
Must not have
Patients with a documented history of cerebrovascular accidents and/or TIA within the past 6 months are not eligible
Patients with a history of intracranial hemorrhage are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group

Summary

This trial will test a combination of 3 drugs - sorafenib, cyclophosphamide, and topotecan - to see if it's effective and safe for patients with neuroblastoma that has resisted or returned after treatment.

Who is the study for?
This trial is for patients under 30 with high-risk neuroblastoma that's come back or didn't respond to treatment. They should have a certain level of bone marrow activity, no recent other cancer treatments, and be able to perform daily activities at least half the time. Not eligible if pregnant, breastfeeding, had an allogeneic transplant, uncontrolled infections or certain heart conditions.
What is being tested?
The study tests combining sorafenib with cyclophosphamide and topotecan in children and young adults with relapsed/refractory neuroblastoma. It aims to find the highest safe dose of sorafenib when used with these drugs for this specific condition.
What are the potential side effects?
Potential side effects include bleeding risks, high blood pressure (which can't be treated during the trial), liver issues indicated by blood tests results outside normal ranges, kidney function changes based on urine analysis results, and possible digestive system effects like increased amylase or lipase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on blood thinners.
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My kidney function, based on creatinine levels, is within the limit for my age and gender.
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I have not had an allogeneic stem cell transplant.
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It has been over 6 weeks since my last 131I-MIBG therapy.
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I am not taking any blood pressure medication.
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I have been diagnosed with neuroblastoma confirmed by tests.
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I do not have a history of unusual bleeding.
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I have a cancerous lesion or lymph node that can be measured and meets the size requirements.
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I have recovered from side effects of my previous cancer treatments.
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I haven't had certain cancer treatments recently.
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I am not on any cancer treatments or radiotherapy currently.
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I haven't taken certain medications that affect drug metabolism in the last 14 days.
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I am not taking medication for irregular heartbeats.
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My blood pressure is within the normal range for my age, height, and gender.
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I am under 30 years old.
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I am expected to live more than 8 weeks and can do some daily activities on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a stroke or mini-stroke in the last 6 months.
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I have never had bleeding in my brain.
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My body surface area is not less than 0.40 m2, making me eligible for the study.
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I have chosen not to participate in the NANT 04-05 study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The maximum tolerated dose of sorafenib given twice each day when given in combination with cyclophosphamide/topotecan for 5 days
The number and types of toxicities of sorafenib when administered in combination with cyclophosphamide and topotecan.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sorafenib and Cyclophosphamide/TopotecanExperimental Treatment3 Interventions
Sorafenib and Cyclophosphamide/Topotecan with growth factor support.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Sorafenib
FDA approved
Topotecan
FDA approved

Find a Location

Who is running the clinical trial?

Cook Children's Health Care SystemOTHER
9 Previous Clinical Trials
5,000,841 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,108 Previous Clinical Trials
357,020 Total Patients Enrolled
10 Trials studying Neuroblastoma
3,825 Patients Enrolled for Neuroblastoma
University of MichiganOTHER
1,857 Previous Clinical Trials
6,437,666 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT02298348 — Phase 1
Cyclophosphamide (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02298348 — Phase 1
~2 spots leftby Dec 2025
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