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 February 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003474
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: February 2004

November 1, 1999
July 23, 2008
August 1998
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Complete list of historical versions of study NCT00003474 on ClinicalTrials.gov Archive Site
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Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Phase II Study of Antineoplastons A10 and AS2-1 in Adult 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:

  • Study the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable glioblastoma multiforme.
  • Describe response, 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 six times a day until the maximum tolerated dose is reached. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression.

Tumors are measured every 2 months during the first year and every 3 months during the second year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued in this study.

Interventional
Phase 2
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: antineoplaston A10
  • Drug: antineoplaston AS2-1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
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DISEASE CHARACTERISTICS:

  • Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy)

    • Measurable disease by MRI or CT scan
  • Brain stem tumor is excluded
  • Tumor must be at least 5 mm

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC at least 2,000/mm3
  • Platelet count at least 50,000/mm3

Hepatic:

  • No liver failure
  • Bilirubin no greater than 2.5 mg/dL
  • SGOT/SGPT no greater than 5 times upper limit

Renal:

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

Cardiovascular:

  • No uncontrolled hypertension
  • No history of congestive heart failure
  • No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

  • No serious lung disease (e.g., severe COPD)

Other:

  • Not pregnant or nursing
  • Fertile patients must use adequate contraception during and for 4 weeks after study
  • No active infection
  • No other serious medical or psychiatric conditions

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since chemotherapy (unless radiologically proven progression)
  • At least 6 weeks since nitrosoureas

Endocrine therapy:

  • Corticosteroids allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 8 weeks since radiotherapy (unless radiologically proven progression)

Surgery:

  • Recovered from prior surgery

Other:

  • No prior antineoplaston therapy
  • Prior cytodifferentiating agent allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003474
CDR0000066511, BRI-BT-20
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Burzynski Research Institute
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Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
February 2004

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