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Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003535
First received: November 1, 1999
Last updated: July 14, 2009
Last verified: June 2009

November 1, 1999
July 14, 2009
August 1993
December 2011   (final data collection date for primary outcome measure)
Response rate based on tumor measurements at 12 weeks [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003535 on ClinicalTrials.gov Archive Site
Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma
Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma

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 is studying how well antineoplaston therapy works in treating children with recurrent or refractory high grade glioma.

OBJECTIVES:

  • Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with high-grade glioma by determining the proportion of patients who experience an objective tumor response.
  • Evaluate the adverse effects of and tolerance to this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of unacceptable toxicity or disease progression. After 12 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Interventional
Phase 2
Masking: Open Label
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
40
Not Provided
December 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed incurable high-grade glioma, glioblastoma multiforme, or anaplastic astrocytoma that is refractory or recurrent, or with residual tumor after standard therapy, including radiotherapy

    • Evidence of tumor by gadolinium-enhanced MRI or contrast-enhanced CT scan
  • No brain stem tumor

PATIENT CHARACTERISTICS:

Age:

  • 6 months to 17 years

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC greater than 1,500/mm^3
  • Platelet count greater than 50,000/mm^3

Hepatic:

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

Renal:

  • Creatinine no greater than 2.5 mg/dL
  • No renal insufficiency

Cardiovascular:

  • No severe heart disease
  • No uncontrolled hypertension
  • No history of congestive heart failure

Pulmonary:

  • No severe lung disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No serious active infections or fever
  • No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No concurrent antineoplastic therapy

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 8 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • No prior antineoplaston therapy
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003535
CDR0000066582, BC-BT-6
Not Provided
Stanislaw R. Burzynski, Burzynski Clinic
Burzynski Research Institute
Not Provided
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
National Cancer Institute (NCI)
June 2009

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