Inhibition of Oral Tumorigenesis by Antitumor B

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.

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Cancer of the Oral Cavity
• Intervention / Treatment: Drug: Anti-tumor B

Detailed Description

Upon initiating study treatment, patients will start taking the study drug. The duration of treatment will depend upon scheduling of their surgery--typically from the time surgery is scheduled it will be seven to 28 days. Four (300 mg) pills will be taken three times per day until the evening prior to surgery.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Medical College of Wisconsin Cancer Center Clinical Trials Office; Phone Number: 8900 866-680-0505; Email: cccto@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital & the Medical College of Wisconsin
      • Contact: Medical College of Wisconsin Cancer Center Trials Office; Phone Number: 414-805-8900; Email: cccto@mcw.edu
      • Principal Investigator: Stuart J. Wong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
2. 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.
3. Clinical stage II-IVA (as defined by the American Joint Committee on Cancer (AJCC), 8th Edition), and amenable to surgical resection.
4. New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a minimum remission of six months following previous definite surgery.
5. History and physical examination by an otolaryngologist and medical oncologist within 14 calendar days of study registration.
6. Zubrod/ECOG Performance status < 2.
7. Age ≥ 18 years.

8. 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).

9. 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)]
   • CCr female = 0.85 x (CrCl male)
10. Total bilirubin < 2 x the institutional upper limit of normal (ULN);
11. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the institutional ULN;

12. Magnesium, calcium, glucose, potassium, and sodium within 14 calendar days prior to registration, with the following required parameters:

    • Magnesium: > 0.9 mg/dl or < 3 mg/dl;
    • Calcium: > 7 mg/dl or < 12.5 mg/dl;
    • Glucose: > 40 mg/dl or < 250 mg/dl;
    • Potassium: > 3 mmol/L or < 6 mmol/L;
    • Sodium: > 130 mmol/L or < 155 mmol/L.
13. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

14. Female subjects must meet one of the following:

    • Postmenopausal for at least one year before enrollment, OR
    • Surgically sterile (i.e., undergone a hysterectomy or bilateral oophorectomy), OR
    • If subject is of childbearing potential (defined as not satisfying either of the above two criteria), agrees to practice two acceptable methods of contraception (combination methods require use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 21days after the last dose of study agent, OR
    • Agrees to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable contraception methods.)

15. Male subjects, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following:

    • Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR
    • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
16. Enrollment on an interventional postoperative study is allowed if study agents do not overlap.
17. Gastric tube drug administration is permissible.

Exclusion Criteria:

1. Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
2. Concurrent use of any medicinal botanical, natural, or other herbal compounds.
3. Planned subtotal or debulking surgery is not permissible.
4. Prior systemic chemotherapy for oral SCC; note that prior chemotherapy for a different cancer is allowable.
5. 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.
6. Severe active comorbidity, such as uncontrolled cardiac disease, infection, and severe chronic obstructive pulmonary disease (COPD).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-tumor B; 1,200 mg three times a day.	Drug: Anti-tumor B; 1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).; Other Names: ATB; ACAPHA; Zeng-Sheng-Ping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Stuart J Wong, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell; Carcinogenesis; Cell Transformation, Neoplastic
• Other Study ID Numbers: PRO00037907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No