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

November 1, 1999
July 23, 2008
November 1998
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00003456 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme

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.

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

Interventional
Phase 2
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: antineoplaston A10
  • Drug: antineoplaston AS2-1
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003456
CDR0000066488, BRI-BT-7
Not Provided
Not Provided
Burzynski Research Institute
Not Provided
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP