Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
Summary
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 is studying how well antineoplaston therapy works in treating patients with advanced mesothelioma.
Description
OBJECTIVES:
- Provide treatment with antineoplastons A10 and AS2-1 to patients with stage IV mesothelioma.
- Describe the response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 IV six times per day until the maximum dose is reached.
Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. After 3 months, patients with stable or responding disease may continue treatment. Patients achieving complete response (CR) continue treatment for at least 8 months beyond CR.
Patients are followed every 2 months for 1 year and then every 3 months for the second year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Study Design
Primary Purpose: Treatment
Conditions
Malignant Mesothelioma
Intervention
antineoplaston A10, antineoplaston AS2-1
Location
Burzynski Clinic
Houston
Texas
United States
77055-6330
Status
Terminated
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00003508
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Mesothelioma, Cystic
A peritoneal mesothelioma affecting mainly young females and producing cysts of variable size and number lined by a single layer of benign mesothelial cells. The disease follows a benign course and is compatible with a normal life expectancy, requiring occasionally partial excision or decompression for relief of pain or other symptoms. Malignant potential is exceptional. (From Holland et al., Cancer Medicine, 3d ed, p1345)
Solitary Fibrous Tumor, Pleural
A rare neoplasm, usually benign, derived from mesenchymal fibroblasts located in the submesothelial lining of the PLEURA. It spite of its various synonyms, it has no features of mesothelial cells and is not related to malignant MESOTHELIOMA or asbestos exposure.
Pleural Effusion, Malignant
Presence of fluid in the PLEURAL CAVITY as a complication of malignant disease. Malignant pleural effusions often contain actual malignant cells.
Mesothelioma
A tumor derived from mesothelial tissue (peritoneum, pleura, pericardium). It appears as broad sheets of cells, with some regions containing spindle-shaped, sarcoma-like cells and other regions showing adenomatous patterns. Pleural mesotheliomas have been linked to exposure to asbestos. (Dorland, 27th ed)
Mixed Tumor, Malignant
A malignant tumor composed of more than one type of neoplastic tissue. (Dorland, 27th ed)
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PubMed Articles
PET-CT in the diagnosis of localized malignant pleural mesothelioma.
A 67-year-old man presented with right-sided chest and shoulder pain. Chest roentgenogram demonstrated a right upper zone shadow. Computed tomography (CT) revealed a pleural mass and adjacent chest wa...
B. Davidson The diagnostic and molecular characteristics of malignant mesothelioma and ovarian/peritoneal serous carcinoma Malignant mesothelioma and ovarian/peritoneal serous carcinoma are two of the...
Malignant pleural mesothelioma is a refractory tumor with poor prognosis associated with asbestos exposure. Pleural effusion is frequently observed in patients with malignant pleural mesothelioma, and...
TLE1 expression in malignant mesothelioma.
Malignant mesothelioma, an aggressive and often lethal tumor commonly associated with asbestos exposure, has been morphologically classified into epithelial, biphasic, and sarcomatoid subtypes. Histol...
Splenic localization of the peritoneal mesothelioma: case report and literature revue.
Peritoneal mesothelioma is a rare form of malignant mesothelioma, making up
