Inhibition of Oral Tumorigenesis by Antitumor B (NCT04278989) | Clinical Trial Compass
CompletedEarly Phase 1
Inhibition of Oral Tumorigenesis by Antitumor B
United States30 participantsStarted 2022-04-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
✓. 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.
✓. 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:
Exclusion criteria
✕. Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
What they're measuring
1
Percent of Ki-67 Positive Cells
Timeframe: Baseline and after surgery (seven to 28 days after baseline)
✕. 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).