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Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme

The recruitment status of this study is unknown because the information has not been verified recently.
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:

MedlinePlus related topics: Cancer
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
Genders Eligible for Study:   Both
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
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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00003456     History of Changes
Other Study ID Numbers: CDR0000066488, BRI-BT-7
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

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 May 16, 2013