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Trial record 1 of 2 for:    burzynski bt-6
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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
  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 is studying how well antineoplaston therapy works in treating children with recurrent or refractory high grade glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate based on tumor measurements at 12 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 1993
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003535

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:
No publications provided

Responsible Party: Stanislaw R. Burzynski, Burzynski Clinic
ClinicalTrials.gov Identifier: NCT00003535     History of Changes
Other Study ID Numbers: CDR0000066582, BC-BT-6
Study First Received: November 1, 1999
Last Updated: July 14, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood high-grade cerebral astrocytoma
recurrent childhood cerebral astrocytoma
childhood cerebral astrocytoma/malignant glioma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014