Inhibition of Oral Tumorigenesis by Antitumor B

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    28
  • sponsor
    Medical College of Wisconsin
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Updated on 16 May 2022
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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.

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.

Details
Condition Squamous Cell Cancer of the Oral Cavity
Treatment placebos, Anti-tumor B
Clinical Study IdentifierNCT04278989
SponsorMedical College of Wisconsin
Last Modified on16 May 2022

Eligibility

 Yes No Not Sure

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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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)
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