Antineoplaston Therapy in Treating Children With Brain Tumors

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  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003458
First received: November 1, 1999
Last updated: June 9, 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 brain tumors.


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 Wtih Brain Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate based on tumor measurements taken 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: September 1996
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 brain tumors by determining the proportion of patients who experience an objective tumor response.
  • Evaluate the adverse effects of and tolerance to this regimen in these children.

OUTLINE: This is an open-label study.

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 disease progression or unacceptable toxicity. Patients achieving 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 (except if medically contraindicated) severe pediatric brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists

    • Histology requirement may be waived for brain stem tumors
  • Measurable tumor by MRI or CT scan

    • Tumor must be at least 5 mm

PATIENT CHARACTERISTICS:

Age:

  • 6 months to 17 years

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC greater than 2000/mm^3
  • Platelet count greater than 50,000/mm^3

Hepatic:

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

Renal:

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

Cardiovascular:

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

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
  • No concurrent immunomodulating agents

Chemotherapy:

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

Endocrine therapy:

  • Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week before study entry)

Radiation therapy:

  • At least 8 weeks since prior radiotherapy and recovered

Surgery:

  • Recovered from any prior surgery

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: NCT00003458

Locations
United States, Texas
Burzynski Clinic Recruiting
Houston, Texas, United States, 77055-6330
Contact: Stanislaw R. Burzynski, MD, PhD    713-335-5697    info@burzynskiclinic.com   
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: NCT00003458     History of Changes
Other Study ID Numbers: CDR0000066490, BC-BT-10
Study First Received: November 1, 1999
Last Updated: June 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
childhood craniopharyngioma
childhood central nervous system germ cell tumor
childhood oligodendroglioma
childhood choroid plexus tumor
recurrent childhood brain stem glioma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood ependymoma
recurrent childhood pineoblastoma

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

ClinicalTrials.gov processed this record on October 29, 2014