Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inhibition of Oral Tumorigenesis by Antitumor B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278989
Recruitment Status : Not yet recruiting
First Posted : February 20, 2020
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Stuart Wong, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE February 19, 2020
First Posted Date  ICMJE February 20, 2020
Last Update Posted Date July 20, 2021
Estimated Study Start Date  ICMJE September 1, 2021
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
Tumor Ki-67 in baseline tumor biopsy compared to resected tumor. [ Time Frame: Baseline and following surgery (seven to 28 days after baseline) ]
KI-67 will be measured as a change in the index from baseline to post-treatment (surgery).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
  • Area under the Curve (AUC) for Saliva. [ Time Frame: Either predose, before lunch or before dinner daily from Day 1 to Day -1 of surgery (seven to 28 days after baseline). ]
    The AUC will be calculated using software. The calculation will be mg/ml X hour.
  • Cmax for Saliva. [ Time Frame: Either predose, before lunch or before dinner daily while taking ATB from Day 1 to Day -1 of surgery (seven to 28 days after baseline). ]
    The Cmax will be calculated using software. The calculation will be ng/ml.
  • NFKB in baseline tumor biopsy compared to resected tumor. [ Time Frame: Baseline and following surgery (seven to 28 days after baseline). ]
    The effect of ATB NF-ĸB signaling pathway will be examined by expression of target genes (cyclin D1 and BCL-XL).
  • RNA-Seq of baseline tumor biopsy compared to resected tumor. [ Time Frame: Baseline and following surgery (seven to 28 days after baseline). ]
    RNA Seq will be performed to identify gene expression signatures to identify genes that may predict for responsiveness or resistance to treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhibition of Oral Tumorigenesis by Antitumor B
Official Title  ICMJE Inhibition of Oral Tumorigenesis by Antitumor B
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Cancer of the Oral Cavity
Intervention  ICMJE
  • Drug: Anti-tumor B
    1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
    Other Names:
    • Zeng-Sheng-Ping
    • ACAPHA
    • ATB
  • Drug: Placebos
    Placebos taken seven to 28 days (dependent on scheduled surgery).
Study Arms  ICMJE
  • Active Comparator: Anti-tumor B
    1,200 mg three times a day.
    Intervention: Drug: Anti-tumor B
  • Placebo Comparator: Placebo
    Placebo taken three times a day.
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2020)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2024
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 cccto@mcw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04278989
Other Study ID Numbers  ICMJE PRO00037907
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stuart Wong, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stuart J Wong, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP