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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

N2013-02 Trial 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.Check my eligibility

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.See study design

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.

N2013-02 Trial 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.

N2013-02 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

N2013-02 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

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cook Children's Health Care SystemOTHER

6 Previous Clinical Trials

5,000,586 Total Patients Enrolled

Dana-Farber Cancer InstituteOTHER

1,080 Previous Clinical Trials

341,215 Total Patients Enrolled

10 Trials studying Neuroblastoma

3,962 Patients Enrolled for Neuroblastoma

University of MichiganOTHER

1,800 Previous Clinical Trials

6,379,122 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

Frequently Asked Questions

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

Are individuals currently being accepted for participation in this research?

"This particular study is no longer accepting patients, as the last update to its listing on clinicaltrials.gov was made on September 28th 2022. However, for those looking for other trials related to neuroblastoma treatment, there are 161 studies currently open and 908 additional ones actively recruiting participants."

Answered by AI

What maladies have been alleviated through this therapeutic approach?

"This therapeutic intervention is widely used in the management of multiple sclerosis, and has demonstrated efficacy against cancerous conditions such as leukemia, myelocytic, acute sarcoma, and retinoblastoma."

Answered by AI

How many participants are receiving treatment through this clinical experiment?

"At this moment, the trial is not recruiting any further participants. The original posting date was April 1st 2015 and it underwent its last edit on September 28th 2022. Should you be searching for alternative trials, there are currently 161 studies involving neuroblastoma actively seeking enrolment as well as 908 other medical studies concerning said treatment that are also accepting patients."

Answered by AI

Is this remedy risk-free for those undergoing it?

"With the limited data available, we have assigned this intervention a safety score of 1 on our scale from 1 to 3. This is due to it being in Phase 1 trials where efficacy and safety are still under investigation."

Answered by AI

Are there any analogous research projects that have investigated this cure?

"Currently, there are 908 live trials for this treatment with 189 in the advanced Phase 3. Philadelphia, Pennsylvania is one of many locations conducting studies on it; across 32589 sites globally."

Answered by AI

At what locales is this clinical experiment being conducted?

"This clinical trial has a total of 12 enrolment sites including Children's Hospital Los Angeles in LA, the Children Hospital of Colorado in Aurora, and Cincinnati Children's Medical Centre. Additional locations are also available for interested patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma

2015. "Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02298348.

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