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Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers
Phase 2
Waitlist Available
Led By Te Vuong, MD
Research Sponsored by Dr. Te Vuong
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month post end of treatment
Awards & highlights
No Placebo-Only Group
Summary
The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this study.
Eligible Conditions
- Anal Squamous Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month post end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post end of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Local tumor response rate
Toxicity
Awards & Highlights
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: NimotuzumabExperimental Treatment2 Interventions
Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity Modulated Radiation Therapy (IMRT)
2010
Completed Phase 1
~60
Nimotuzumab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Dr. Te VuongLead Sponsor
2 Previous Clinical Trials
2 Total Patients Enrolled
YM BioSciencesIndustry Sponsor
13 Previous Clinical Trials
1,165 Total Patients Enrolled
Te Vuong, MDPrincipal InvestigatorJewish General Hospital
6 Previous Clinical Trials
422 Total Patients Enrolled