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| Sponsor: | Burzynski Research Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003514 |
Purpose
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 neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Merkel Cell Carcinoma Islet Cell Carcinoma Neuroendocrine Carcinoma Pituitary Tumor |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 Procedure: alternative product therapy Procedure: biological therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: differentiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Metastatic or Incurable Neuroendocrine Tumors |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Texas | |
| Burzynski Clinic | |
| Houston, Texas, United States, 77055-6330 | |
| Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
More Information
| Study ID Numbers: | CDR0000066557, BC-NE-2 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 4, 2006 |
| ClinicalTrials.gov Identifier: | NCT00003514 History of Changes |
| Health Authority: | United States: Federal Government |
|
ACTH-producing pituitary tumor prolactin-producing pituitary tumor growth hormone-producing pituitary tumor recurrent pituitary tumor TSH producing pituitary tumor |
nonfunctioning pituitary tumor somatostatinoma stage III Merkel cell carcinoma recurrent Merkel cell carcinoma neuroendocrine carcinoma |
|
Carcinoma, Neuroendocrine Pancreatic Neoplasms Neoplasms, Nerve Tissue Pituitary Neoplasms Central Nervous System Neoplasms Brain Diseases Neoplasms by Site Neoplasms, Germ Cell and Embryonal Hypothalamic Neoplasms Nervous System Neoplasms Endocrine Gland Neoplasms Hypothalamic Diseases Digestive System Neoplasms Neoplasms by Histologic Type Pituitary Diseases |
Carcinoma, Islet Cell Nervous System Diseases Endocrine System Diseases Central Nervous System Diseases Supratentorial Neoplasms Neuroendocrine Tumors Carcinoma Carcinoma, Merkel Cell Neuroectodermal Tumors Brain Neoplasms Neoplasms Digestive System Diseases Pancreatic Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |