Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00003456

First received: November 1, 1999

Last updated: July 23, 2008

Last verified: July 2004

History of Changes

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 studies the effectiveness of antineoplaston therapy in treating patients who have glioblastoma multiforme.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: antineoplaston A10 Drug: antineoplaston AS2-1	Phase 2


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Glioblastoma Gliosarcoma Glioma Neuroepithelioma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):


Study Start Date:	November 1998

Detailed Description:

OBJECTIVES:

Determine the objective response rate to escalating doses of antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme.
Assess tolerance to and side effects of this regimen in these patients.

OUTLINE: Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 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 CR.

Tumors are measured after 1 month, every 1-2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Not specified

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed glioblastoma multiforme
Tumor subtotally resected or biopsied
- Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography
No brain stem tumor

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

More than 4 months

Hematopoietic:

WBC at least 1,500/mm^3
Platelet count at least 50,000/mm^3
Hemoglobin at least 10 g/dL

Hepatic:

No hepatic failure
Bilirubin no greater than 2.5 mg/dL
SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

Creatinine no greater than 2.5 mg/dL
No history of renal conditions that would contraindicate high dosages of sodium

Cardiovascular:

No uncontrolled hypertension

Other:

Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior immunotherapy
No concurrent immunomodulatory agents

Chemotherapy:

No prior chemotherapy
No concurrent antineoplastic agents

Endocrine therapy:

Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

No prior radiotherapy

Surgery:

See Disease Characteristics
Recovered from any prior surgery

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003456

Locations


United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330

Sponsors and Collaborators

Burzynski Research Institute

Investigators


Study Chair:	Stanislaw R. Burzynski, MD, PhD	Burzynski Research Institute

More Information


ClinicalTrials.gov Identifier:	NCT00003456 History of Changes
Obsolete Identifiers:	NCT00003474
Other Study ID Numbers:	CDR0000066488 BRI-BT-7
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008

Keywords provided by National Cancer Institute (NCI):


adult glioblastoma adult giant cell glioblastoma adult gliosarcoma

Additional relevant MeSH terms:


Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors	Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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