Inhibition of Oral Tumorigenesis by Antitumor B

NCT04278989 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: PRO00037907
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a window of opportunity study of Anti-tumor B (ATB). Anti-tumor B is a botanical agent composed of six Chinese herbs: Sophora tonkinensis, Polygonum bistorta, Prunella vulgaris, Sonchus brachyotus, Dictamnus dasycarpus, and Dioscorea bulbifera.

Conditions

Squamous Cell Cancer of the Oral Cavity

Outcome Measures

Primary Outcomes (1)

• Percent of Ki-67 Positive Cells

  This measure is the immunohistochemical evaluation using the antihuman Ki-67 monoclonal antibody MIB-1 and reporting the percentage of positively stained malignant cells.

  Baseline and after surgery (seven to 28 days after baseline)

Study Arms (1)

Anti-tumor B

EXPERIMENTAL

1,200 mg three times a day.

Drug: Anti-tumor B

Interventions

Anti-tumor B DRUG

1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).

Also known as: Zeng-Sheng-Ping, ACAPHA, ATB

Anti-tumor B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• In the event that the diagnosis of squamous cell cancer is made by an outside pathologist, hence not verified, the patient can start study agent administration but histological confirmation of squamous cell cancer (SCC) of the oral cavity (or histologic variants of SCC) by the pathologist must happen within seven days of registration in order to continue protocol therapy. Note: patients whose confirmatory biopsy fails to demonstrate invasive carcinoma will be excluded from continued participation in the study and considered a screen failure.
• Clinical stage II-IVA (as defined by the American Joint Committee on Cancer (AJCC), 8th Edition), and amenable to surgical resection.
• New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a minimum remission of six months following previous definite surgery.
• History and physical examination by an otolaryngologist and medical oncologist within 14 calendar days of study registration.
• Zubrod/ECOG Performance status \< 2.
• Age ≥ 18 years.
• Complete Blood Count (CBC)/differential obtained within 14 calendar days prior to registration, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3;
• Platelets ≥ 100,000 cells/mm\^3;
• Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable).
• Adequate renal and hepatic function within 14 calendar days prior to registration, defined as follows:
• Serum creatinine \< 1.5 mg/dl or creatinine clearance (CCr) ≥ 50 ml/min within 14 calendar days prior to registration, determined by 24-hour collection or estimated by Cockcroft-Gault formula:
• CCr male = \[(140 - age) x (wt in kg)\]
• \[(Serum Cr mg/dl) x (72)\]

You may not qualify if:

• Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
• Concurrent use of any medicinal botanical, natural, or other herbal compounds.
• Planned subtotal or debulking surgery is not permissible.
• Prior systemic chemotherapy for oral SCC; note that prior chemotherapy for a different cancer is allowable.
• Prior radiotherapy for oral SCC is permissible if disease free for one year since prior oral cancer treatment and free of significant late radiation effects.
• Severe active comorbidity, such as uncontrolled cardiac disease, infection, and severe chronic obstructive pulmonary disease (COPD).

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Interventions

antitumor A

Results Point of Contact

• Title: Stuart J. Wong, MD
• Organization: Medical College of Wisconsin

swong@mcw.edu

414-805-4600

Study Officials

• Stuart J Wong, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 20, 2020
• Study Start: April 22, 2022
• Primary Completion: May 19, 2025
• Study Completion: June 5, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)