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Anti-cancer agent

Cyclophosphamide for Neuroblastoma

Phase 2
Waitlist Available
Research Sponsored by Giselle SaulnierSholler
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 2 years
Awards & highlights

Study Summary

This trial will test if a combination of drugs is effective in treating neuroblastoma or medulloblastoma that has returned or is resistant to treatment.

Eligible Conditions
  • Neuroblastoma
  • Medulloblastoma

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Radiological Response in Participants Using the RECIST Criteria
Number of Participants With Related Adverse Events as a Measure of Safety and Tolerability
Secondary outcome measures
Biology studies to include: genomic analysis of cells pre- and post- treatment, correlation of in vitro response to in vivo response, flow cytometry of tumor burden in bone marrow and biomarker development.
Evaluate the correlation between the pharmacologic serum levels of nifurtimox (in combination with cyclophosphamide and topotecan) with tumor response.
Quality of life and neurocognitive evaluation/questionnaire.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NifurtimoxExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Nifurtimox
2008
Completed Phase 3
~510
Topotecan
2017
Completed Phase 3
~2400

Find a Location

Who is running the clinical trial?

Giselle SaulnierShollerLead Sponsor
21 Previous Clinical Trials
2,106 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,479 Patients Enrolled for Neuroblastoma
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,125 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,536 Patients Enrolled for Neuroblastoma
BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,326,866 Total Patients Enrolled
1 Trials studying Neuroblastoma
31 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.

How is Cyclophosphamide employed to treat medical conditions?

"Cyclophosphamide is frequently used to manage multiple sclerosis, yet it has also been proven effective in treating leukemia, myelocytic acute sarcoma and retinoblastoma."

Answered by AI

Are there still opportunities for patients to participate in this medical research?

"Unfortunately, this particular study is no longer actively searching for participants. This trial was initially posted on February 1st 2008 and the latest update occured September 28th 2022. However, those hoping to participate in a clinical trial can find 216 medulloblastoma studies presently recruiting patients and 854 Cyclophosphamide trials accepting enrollees."

Answered by AI

What potential hazards are associated with Cyclophosphamide treatment?

"While yet to be proven effective, Cyclophosphamide has undergone clinical testing and earned a safety rating of 2 on our team's scale."

Answered by AI

Could you please elucidate other experiments that have been performed with Cyclophosphamide?

"Currently, 854 Cyclophosphamide clinical trials are listed as active. Of these, 168 have reached Phase 3. Most sites conducting research on this drug are in the vicinity of Philadelphia, Pennsylvania but there are over 30 thousand other locations around the world with studies underway."

Answered by AI

How many individuals have been accepted into this research project?

"The clinical trial in question is no longer a viable option as it has concluded recruitment. This study was initially posted on February 1st 2008, and last updated September 28th 2022. For those seeking alternative studies, there are presently 216 trials involving medulloblastoma and 854 employing Cyclophosphamide that require enrolment."

Answered by AI

How many venues are being utilized to conduct this investigation?

"At the moment, 15 medical centres are admitting patients into this trial. Locations range from Dallas to Charleston and Minneapolis with other sites scattered in between. To reduce travel burdens, it is recommended that participants select a clinical site closest to them."

Answered by AI
~6 spots leftby Apr 2025