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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003489 |
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have advanced head and neck cancer.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Head and Neck |
Estimated Enrollment: | 40 |
Study Start Date: | August 1998 |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection six times per day until the maximum tolerated dose is reached.
Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. After 2 months, patients with stable or responding disease may continue treatment. Patients achieving complete response (CR) continue treatment for 8 months beyond CR.
Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Measurable disease by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
Burzynski Clinic | |
Houston, Texas, United States, 77055-6330 |
Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Study ID Numbers: | CDR0000066527, BC-HN-2 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003489 |
Health Authority: | United States: Federal Government |
stage IV salivary gland cancer recurrent salivary gland cancer recurrent lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity |
recurrent inverted papilloma of the paranasal sinus and nasal cavity recurrent midline lethal granuloma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity stage IV inverted papilloma of the paranasal sinus and nasal cavity stage IV midline lethal granuloma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage IV lymphoepithelioma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity recurrent adenoid cystic carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity |
Squamous cell carcinoma Carcinoma, Basal Cell Granuloma Adenoid cystic carcinoma Dental Caries Recurrence Carcinoma Epidermoid carcinoma Nasopharyngeal carcinoma |
Carcinoma, Adenoid Cystic Head and Neck Neoplasms Carcinoma, squamous cell Laryngeal carcinoma Hypopharyngeal cancer Carcinoma, Squamous Cell Papilloma Salivary Gland Diseases |
Neoplasms Neoplasms by Site |