Trial Information

Summary: Phase II Study Of Antineoplastons A10 And AS2-1 In Patients With Carcinoma Of The Head And Neck

Provide the treatment for incurable carcinoma of the head and neck.

Describe the patients' response, tolerance to, and the side effects of this regimen.

Inclusion Criteria:

• Patients should have histologically confirmed incurable carcinoma of the head and neck and are unlikely to respond to existing therapeutic regimens. Eligibility for this study is specifically limited to patients who have metastatic disease or disease that is not curable with surgery or radiation.
• There will be no exclusion based on tumor size or systemic metastases.
• Patients must have measurable disease by contrast enhanced CT or MRI performed within 14 days of the beginning of the treatment. The minimum size of the lesion to be considered malignant and measurable should more than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal and femoral areas and not less that 0.5 cm in the largest diameter for the other localization. Small lesions, 0.5 to 2 cm in diameter which cannot be accurately measured on scans should be excluded from evaluation, but they should be included if they can be measured accurately. At least four weeks must have elapsed between termination of treatment with chemotherapy and /or immunotherapy and the performance of the baseline scans. Any lesion that has been irradiated will not be used as a measurable lesion for the purposes of assessment of response to antineoplastons, although if any previously irradiated lesions reveal greater than 50% increase in the sum of the products of the greatest perpendicular diameter antineoplaston treatment, that will be considered to be evidence of disease progression and treatment failure. A decrease in the number and intensity of lesions on the bone scan is not sufficient criterion for objective response unless it is supported by x-rays, CT scans or MRI
• Patients who have previously received radiation therapy, chemotherapy, immunotherapy or cytodifferentiating agent are eligible.
• Subsection deleted.
• Patients may be male or female. If female, the patient must not be pregnant or breast-feeding an infant, and either incapable of becoming pregnant or currently using contraceptive methods. Acceptable methods include the birth control pill, use of a diaphragm, intrauterine device, or condom by the patient's sexual partner. If male, the patient should use appropriate contraception, such as condoms, during the study and at least 4 weeks following completion of the study.
• The patients must be 16 years of age or older.
• Patient must sign the Informed Consent Form indicating an awareness of the experimental nature of this study. In the event that the patient has impairment of higher intellectual function, example aphasia, then the patient's legal next of kin or legal guardian must sign the Informed Consent Form indicating an awareness of the experimental nature of the study (Appendix B).
• Patient must fully recover from the operative procedure and have life expectancy of two months or more. The patient's Performance Status should be consistent with outpatient therapy, i.e. 60% to 100% Karnofsky. The use of corticosteroids is permitted, if necessary. It is recommended that the smallest dose be used and recorded.
• Patient must have a relatively normal hematological, hepatic and renal function, a white blood count of at least 2000/ mm3 and a platelet count of at least 50,000/ mm3.
• Patients must have no evidence of hepatic insufficiency or renal insufficiency, total bilirubin within normal range and creatinine concentration in serum not higher than 2.5 mg/ml, and SGOT and SGPT not higher than five times the upper limit.
• Patients must recover from the adverse effect of previous therapy. At least eight weeks must have elapsed since the last dose of radiation therapy and at least four weeks must have elapsed since the last dose of chemotherapy (six weeks for nitrosoureas) or immunotherapy. Patients with multiple tumors who have received radiation therapy to some but not all of their tumors, may be admitted earlier than eight weeks from the last dose of radiation therapy. However, for such patients pretreatment measurement of irradiated lesions shall be made not earlier than eight weeks from the last dose of radiation therapy.

EXCLUSION CRITERIA:

• Failure to meet all inclusion criteria.
• Patient either pregnant or breast-feeding an infant.
• Patient is a high medical or psychiatric risk, having non-malignant systemic disease which would, in the opinion of the investigator, make therapy with an investigational drug unwise.
• Patient is incompetent to give his informed consent to treatment. However, the patient may be admitted if a legally-appointed guardian gives consent.
• Presence of active infection.
• Patients with known chronic heart failure and serious lung disease, such as severe COPD.
• Patients with hypertension are excluded unless the blood pressure is adequately controlled. Patients who have had prior Antineoplaston treatment should be excluded from this protocol.
• Patients who do not have adequate hepatic function.
• The patients with hypertension, history of congestive heart failure, or history of cardiovascular renal conditions that medically contraindicate administration of high dosages of sodium are not to be enrolled on treatment.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.