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Monoclonal Antibodies

SGN-00101 for Cervical Dysplasia

Phase 2

Waitlist Available

Research Sponsored by Dana-Farber/Brigham and Women's Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed grade II or III cervical intraepithelial neoplasia

Accessible, definable, and entirely visible cervical lesions persisting after biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a drug to see if it can prevent cervical cancer in patients with a precancerous condition and the human papillomavirus.

Who is the study for?

This trial is for adults over 18 with grade II or III cervical intraepithelial neoplasia and HPV-16. Participants must have visible cervical lesions, no severe allergies, no other cancers (except nonmelanoma skin cancer), not be pregnant/nursing, use contraception if fertile, and have a normal immune system. They can't join if they've had recent treatments that affect the immune system or are HIV positive.Check my eligibility

What is being tested?

The study is testing SGN-00101's effectiveness in preventing cervical cancer in patients with early changes in their cervix cells due to HPV-16. It's a phase II trial where participants are randomly chosen to receive either SGN-00101 or no treatment to compare outcomes.See study design

What are the potential side effects?

While specific side effects of SGN-00101 aren't detailed here, chemoprevention drugs like this one could potentially cause mild to moderate reactions at the site of application, flu-like symptoms, fatigue, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cervical condition is confirmed as moderate or severe pre-cancer.

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My cervical cancer lesion is visible and remained after a biopsy.

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I had a thorough cervical exam after my biopsy.

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I do not have any infections that need treatment.

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I have had skin cancer but no other types of cancer.

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I do not have a blood clotting disorder that needs treatment.

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I am willing to have a procedure to remove abnormal tissue.

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I have tested positive for HPV 16.

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I am 18 years old or older.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I do not have Lupus, Diabetes, Multiple Sclerosis, or Myasthenia Gravis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber/Brigham and Women's Cancer CenterLead Sponsor

2 Previous Clinical Trials

1,072 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,153 Total Patients Enrolled

138 Trials studying Precancerous Conditions

44,450 Patients Enrolled for Precancerous Conditions

Kristin A. Keefe, MDStudy ChairDana-Farber/Brigham and Women's Cancer Center

Media Library

SGN-00101 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00060099 — Phase 2

Precancerous Conditions Research Study Groups:

Precancerous Conditions Clinical Trial 2023: SGN-00101 Highlights & Side Effects. Trial Name: NCT00060099 — Phase 2

SGN-00101 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00060099 — Phase 2

Frequently Asked Questions

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

Has this particular therapeutic option received regulatory clearance?

"The safety of this particular therapy was accorded a rating of 2, due to the fact that there is still empirical evidence required for its efficacy, despite some data having been collected regarding its security."

Answered by AI

Is there still availability for participation in this clinical experiment?

"The entry for this trial on clinicaltrials.gov indicates that recruitment is no longer taking place, as the last updates were made on November 5th 2013. However, 71 other ongoing studies are currently seeking patients to join their research initiatives."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia

2003. "SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00060099.