Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer

NCT00003489 | Terminated Phase 2 FDA Drug

• 2 other identifiers: CDR0000066527BC-HN-02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

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

Study Arms (1)

Antineoplaston therapy

EXPERIMENTAL

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)

Interventions

Antineoplaston therapy (Atengenal + Astugenal) DRUG

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.

Also known as: A10 (Atengenal); AS2-1 (Astugenal)

Antineoplaston therapy

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Burzynski Research Institute: lead

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

Related Links

• Burzynski Research Institute
• Burzynski Clinic

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Paranasal Sinus Neoplasms; Oropharyngeal Neoplasms; Salivary Gland Neoplasms

Interventions

antineoplaston A10; antineoplaston AS 2-1

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Nose Neoplasms; Nose Diseases; Paranasal Sinus Diseases; Salivary Gland Diseases

Study Officials

• Stanislaw R. Burzynski, MD, PhD

  Burzynski Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: May 6, 1996
• Primary Completion: April 3, 1998
• Study Completion: April 3, 1998
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)