Clinical Trials /

Inhibition of Oral Tumorigenesis by Antitumor B

NCT04278989

Description:

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.

Related Conditions:
  • Oral Cavity Squamous Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Inhibition of Oral Tumorigenesis by Antitumor B
  • Official Title: Inhibition of Oral Tumorigenesis by Antitumor B

Clinical Trial IDs

  • ORG STUDY ID: PRO00037907
  • NCT ID: NCT04278989

Conditions

  • Squamous Cell Cancer of the Oral Cavity

Interventions

DrugSynonymsArms
Anti-tumor BZeng-Sheng-Ping, ACAPHA, ATBAnti-tumor B
PlacebosPlacebo

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Anti-tumor BActive Comparator1,200 mg three times a day.
  • Anti-tumor B
PlaceboPlacebo ComparatorPlacebo taken three times a day.
  • Placebos

Eligibility Criteria

        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             be withdrawn by the subject at any time without prejudice to future medical care.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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Tumor Ki-67 in baseline tumor biopsy compared to resected tumor.
Time Frame:Baseline and following surgery (seven to 28 days after baseline)
Safety Issue:
Description:KI-67 will be measured as a change in the index from baseline to post-treatment (surgery).

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Medical College of Wisconsin

Last Updated

May 3, 2021