Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer

Study Overview
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Brief Summary
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Current therapies for advanced Head and Neck Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Head and Neck Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Head and Neck Cancer.

Detailed Description
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Advanced Head and Neck Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: To determine the efficacy of Antineoplaston therapy in patients with advanced Head and Neck Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). To determine the safety and tolerance of Antineoplaston therapy in patients with advanced Head and Neck Cancer. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Official Title
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Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Head and Neck

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Antineoplaston therapy (Atengenal + Astugenal)


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed cancer of the head and neck that is unlikely to respond to existing therapy and for which no curative therapy exists Metastatic disease OR incurable with surgery or radiation Measurable disease by CT scan or MRI Tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic: No hepatic insufficiency Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 2.5 mg/dL Renal: No renal insufficiency Creatinine no greater than 2.5 mg/dL No renal conditions that contraindicate high dosages of sodium Cardiovascular: No chronic heart failure No uncontrolled hypertension No history of congestive heart failure No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease (e.g., severe chronic obstructive pulmonary disease) Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study participation No other serious medical or psychiatric conditions No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulatory agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic therapy Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics At least 8 weeks since prior radiotherapy (unless multiple tumors) and recovered Surgery: See Disease Characteristics Other: Prior cytodifferentiating agents allowed

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antineoplaston therapy<br>Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. | Drug: Antineoplaston therapy (Atengenal + Astugenal)<br>* Patients with Advanced Head and Neck Cancer Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.<br>* Other names: A10 (Atengenal); AS2-1 (Astugenal);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Head and Neck Cancer, Recurrent Head and Neck Cancer, Oral Cavity Cancer, Nasopharyngeal Cancer, Hypopharyngeal Cancer, Laryngeal Cancer, Nasal Cavity Cancer, Paranasal Sinus Cancer, Oropharyngeal Cancer, Salivary Gland Cancer, Stage IV Head and Neck Cancer