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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003453 |
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 stage IV adrenal gland cancer.
Condition | Intervention | Phase |
---|---|---|
Adrenocortical Carcinoma |
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 Adrenal Gland |
Estimated Enrollment: | 40 |
Study Start Date: | August 1996 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 IV over a minimum of 1 hour 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 3 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.
Patients are followed every 2 months for the first year and then every 3 months for the second year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
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:
United States, Texas | |
Burzynski Clinic | Recruiting |
Houston, Texas, United States, 77055-6330 | |
Contact: Stanislaw R. Burzynski, MD, PhD 713-335-5697 info@burzynskiclinic.com |
Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Responsible Party: | Burzynski Clinic ( Stanislaw R. Burzynski ) |
Study ID Numbers: | CDR0000066485, BC-AD-2 |
Study First Received: | November 1, 1999 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003453 History of Changes |
Health Authority: | Unspecified |
stage IV adrenocortical carcinoma recurrent adrenocortical carcinoma |
Adrenocortical Carcinoma Adrenal Gland Diseases Endocrine System Diseases Recurrence Carcinoma Adrenal Gland Neoplasms Adrenal Cortex Neoplasms |
Endocrinopathy Adenocarcinoma Adrenal Cortex Diseases Epinephrine Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms by Histologic Type Adrenocortical Carcinoma Adrenal Gland Diseases Endocrine System Diseases Carcinoma Neoplasms Adrenal Gland Neoplasms |
Neoplasms by Site Adrenal Cortex Neoplasms Adenocarcinoma Adrenal Cortex Diseases Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |