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Antitumor B for Oral Cancer

Phase < 1
Waitlist Available
Led By Stuart Wong, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Zubrod Score/Eastern Cooperative Oncology Group (ECOG) Performance status < 2.
Clinical stage II-IVA (as defined by the American Joint Committee on Cancer, 8th Edition) and amenable to surgical resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights

Study Summary

This trial is designed to see the effects of an oral agent on cancer patients between the time of their cancer diagnosis and their cancer surgery.

Who is the study for?
This trial is for adults over 18 with a new diagnosis of oral cancer, specifically stage II-IVA squamous cell carcinoma that can be surgically removed. Participants should have a good performance status, meaning they're fairly active and able to care for themselves. They must start the treatment within 7 days of joining the trial and take it for at least a week.Check my eligibility
What is being tested?
The study tests Antitumor B's effects on oral cancer patients during the short period between their diagnosis and surgery. It focuses on how the body processes the drug (pharmacokinetics) rather than its effectiveness in shrinking tumors.See study design
What are the potential side effects?
Since this summary does not provide specific side effects of Antitumor B, we can assume typical side effects may include reactions at the site where it's given, fatigue, nausea or other digestive issues, blood count changes affecting immunity or clotting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my self-care activities and am up more than 50% of my waking hours.
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My cancer is at a stage where surgery is possible.
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I am 18 years old or older.
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I have been diagnosed with squamous cell cancer of the mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve (AUC) for Maackiain in Plasma
Area Under the Curve (AUC) for Maackiain in Saliva
Area Under the Curve (AUC) for Matrine in Saliva
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Antitumor BExperimental Treatment1 Intervention
ATB will be administered on an outpatient basis.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,483 Total Patients Enrolled
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,577 Total Patients Enrolled
Stuart Wong, MDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
142 Total Patients Enrolled

Media Library

Antitumor B (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03459729 — Phase < 1
Squamous Cell Carcinoma Research Study Groups: Antitumor B
Squamous Cell Carcinoma Clinical Trial 2023: Antitumor B Highlights & Side Effects. Trial Name: NCT03459729 — Phase < 1
Antitumor B (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03459729 — Phase < 1

Frequently Asked Questions

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

What is the current number of individuals trialing this clinical research?

"Affirmative. Clinicaltrials.gov shows that this medical trial, initially posted on August 24th 2021, is now actively seeking participants. Approximately 6 individuals are needed at 1 site to complete the study's desired sample size."

Answered by AI

What risks are associated with the utilization of Antitumor B?

"Due to its Phase 1 status, our team at Power assigned Antitumor B a safety score of 1 as there is scant evidence in support of both efficacy and security."

Answered by AI

Is the enrollment period for this research initiative still open?

"Affirmative. The information hosted on clinicaltrials.gov corroborates that this trial, which was made public on August 24th 2021, is actively recruiting participants at the moment. 6 individuals are required to be enrolled from 1 medical site."

Answered by AI
~2 spots leftby Apr 2025