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Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme - Article


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Clinical Trial: Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme

This study is no longer recruiting patients.

Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
adult glioblastoma
 Drug: antineoplaston A10
 Drug: antineoplaston AS2-1
 Procedure: alternative product therapy
 Procedure: biological response modifier therapy
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: differentiation therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Glioblastoma Multiforme

Further Study Details: 

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 above,  Genders Eligible for Study:  Both

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:

Endocrine therapy:

  • Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from any prior surgery

Location Information


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

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066488; BRI-BT-7
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003456
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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September 6, 2008



Page Updated: September 6, 2005
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