Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer
Condition: Squamous Cell Carcinoma of the Oral Cavity
MeSH terms: Mouth Neoplasms
Intervention: Antitumor B
Intervention description: Study participants will take the natural botanical compound ATB during a short window (seven to 28 days). It will be administered at a dose of 1200 mg three times per day (roughly spaced every 8 hours).
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anti-tumor B; ACAPHA; Pharmacokinetics

Summary:

      A Window of Opportunity Clinical Trial. This study design permits examination of effects of
      an oral agent on cancer patients during the "window" between diagnosis of their cancer and
      their definitive cancer surgery. Similar to a phase 0 study, the trial design permits
      examination of the biologic effects of an agent; in this study pharmacokinetic properties
      will be examined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 7 days of registration in order to continue study agent
             administration.

          -  Clinical stage II-IVA (as defined by the American Joint Committee on Cancer, 8th
             Edition [see Amin, 2017]) and amenable to surgical resection

          -  New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a
             minimum remission of 6 months following previous definite surgery

          -  History and physical examination by an otolaryngologist and medical oncologist within
             14 calendar days of study registration

          -  Study agent administration should start within 7 days of registration

          -  Patient must receive administration of study agent for a minimum of 7 days

          -  Zubrod Score/Eastern Cooperative Oncology Group (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/mm^3;

               -  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:

             o 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) within 14 calendar
             days prior to registration

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the
             institutional ULN within 14 calendar days prior to registration

          -  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.

          -  Female patients must meet one of the following:

               -  Postmenopausal for at least one year before the screening visit, or

               -  Surgically sterile (e.g., undergone a hysterectomy or bilateral oophorectomy), or

               -  If the subject is of childbearing potential (defined as not satisfying either of
                  the above two criteria), agree to practice two acceptable methods of
                  contraception (combination methods requires 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 90 days after the last dose of study agent, AND

               -  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
                  contraception methods.)

          -  Male patients, even if surgically sterilized (e.g., status post vasectomy), 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

               -  Must also adhere to the guidelines of any study-specific pregnancy prevention
                  program, if applicable, 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, post ovulation methods] and withdrawal are not acceptable methods
                  of contraception.)

          -  Patients must be deemed able to comply with the study plan.

          -  Gastric tube study agent administration is permissible.

          -  Patients must provide study-specific informed consent prior to study entry.

        Exclusion Criteria:

          -  History of active liver disease

          -  Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or
             fetus.

          -  Concurrent use of any medicinal botanical, natural, or other herbal compound/s that
             the study PI believes could potentially impact the results/objectives of this study

          -  Planned subtotal or debulking surgery, as determined by enrolling physician
             determination, 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 1 year since prior
             oral cancer treatment and free of significant late radiation effects.

          -  Severe active comorbidity such as uncontrolled cardiac disease, infection, severe
             Chronic Obstructive Pulmonary Disease (COPD).