search
Back to results

Inhibition of Oral Tumorigenesis by Antitumor B

Primary Purpose

Squamous Cell Cancer of the Oral Cavity

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anti-tumor B
Placebos
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Cancer of the Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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. Clinical diagnosis of oral cavity squamous cell cancer.
  3. 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.
  4. Clinical stage II-IVA (as defined by the American Joint Committee on Cancer (AJCC), 8th Edition), and amenable to surgical resection.
  5. New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a minimum remission of six months following previous definite surgery.
  6. History and physical examination by an otolaryngologist and medical oncologist within 14 calendar days of study registration.
  7. Zubrod/ECOG Performance status < 2.
  8. Age ≥ 18 years.
  9. 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/mm3;
    • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable).
  10. 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)
  11. Total bilirubin < 2 x the institutional upper limit of normal (ULN);
  12. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the institutional ULN;
  13. 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.
  14. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  15. 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.)
  16. 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.)
  17. Enrollment on an interventional postoperative study is allowed if study agents do not overlap.
  18. 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).

Sites / Locations

  • Froedtert Hospital & the Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Anti-tumor B

Placebo

Arm Description

1,200 mg three times a day.

Placebo taken three times a day.

Outcomes

Primary Outcome Measures

Tumor Ki-67 in baseline tumor biopsy compared to resected tumor.
KI-67 will be measured as a change in the index from baseline to post-treatment (surgery).

Secondary Outcome Measures

Full Information

First Posted
February 19, 2020
Last Updated
July 14, 2023
Sponsor
Medical College of Wisconsin
search

1. Study Identification

Unique Protocol Identification Number
NCT04278989
Brief Title
Inhibition of Oral Tumorigenesis by Antitumor B
Official Title
Inhibition of Oral Tumorigenesis by Antitumor B
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blinded, placebo-control window of opportunity study of Anti-tumor B versus placebo. 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.
Detailed Description
One of the most promising chemopreventive agents to prevent head and neck cancer is Antitumor B (ATB), a Chinese herbal mixture. This randomized Window of Opportunity trial will enroll patients with resectable stage I-IVB squamous cell cancer of the oral cavity who are candidates for surgical tumor resection. Participants will agree to allow a portion of the standard of care (diagnostic tumor biopsy) to be used for the study, and to take study agents or placebo for a duration (14 to 21 days) until the time of their surgery. A second, post-treatment tumor biopsy is not needed because the OR-resected tumor will serve this purpose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Cancer of the Oral Cavity

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti-tumor B
Arm Type
Active Comparator
Arm Description
1,200 mg three times a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo taken three times a day.
Intervention Type
Drug
Intervention Name(s)
Anti-tumor B
Other Intervention Name(s)
Zeng-Sheng-Ping, ACAPHA, ATB
Intervention Description
1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebos taken seven to 28 days (dependent on scheduled surgery).
Primary Outcome Measure Information:
Title
Tumor Ki-67 in baseline tumor biopsy compared to resected tumor.
Description
KI-67 will be measured as a change in the index from baseline to post-treatment (surgery).
Time Frame
Baseline and following surgery (seven to 28 days after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Clinical diagnosis of oral cavity squamous cell cancer. 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. 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/mm3; 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)] CCr female = 0.85 x (CrCl male) Total bilirubin < 2 x the institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the institutional ULN; 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. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 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.) 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.) Enrollment on an interventional postoperative study is allowed if study agents do not overlap. Gastric tube drug administration is permissible. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical College of Wisconsin Cancer Center Clinical Trials Office
Phone
414-805-8900
Email
cccto@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart J Wong, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital & the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical College of Wisconsin Cancer Center Trials Office
Phone
414-805-8900
Email
cccto@mcw.edu
First Name & Middle Initial & Last Name & Degree
Stuart J. Wong, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Inhibition of Oral Tumorigenesis by Antitumor B

We'll reach out to this number within 24 hrs