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Antineoplaston Therapy in Treating Patients With Brain Tumors

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008

Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003457
  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 patients with brain tumors.


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

MedlinePlus related topics:   Brain Cancer    Cancer   

ChemIDplus related topics:   Antineoplaston A10    Antineoplaston AS 2-1   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Tumors

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 ]

Study Start Date:   July 1996
Estimated Primary Completion Date:   December 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening brain tumors.
  • Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 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 reaching CR. Patients achieving partial response or stable disease continue treatment until disease progression.

Tumors are measured every 1-3 months for 2 years, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter.

PROJECTED ACCRUAL: Not specified

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed (except brain stem locations) brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists
  • Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron emission tomography
  • Tumor must be at least 5 mm
  • Ineligible for other BRI brain tumor protocols

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Hemoglobin at least 9 g/dL
  • WBC at least 2,000/mm^3
  • Platelet count at least 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 history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

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

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)
  • No concurrent antineoplastic agents

Endocrine therapy:

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

Radiotherapy:

  • At least 8 weeks since prior radiotherapy

Surgery:

  • Must recover from prior surgery

Other:

  • Prior cytodifferentiating agent allowed
  • No prior antineoplaston therapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003457

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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000066489, BC-BT-9
First Received:   November 1, 1999
Last Updated:   September 10, 2008
ClinicalTrials.gov Identifier:   NCT00003457
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor  
ACTH-producing pituitary tumor  
TSH producing pituitary tumor  
adult brain stem glioma  
adult craniopharyngioma  
adult medulloblastoma  
adult meningioma  
adult glioblastoma  
adult anaplastic astrocytoma  
adult myxopapillary ependymoma  
adult anaplastic ependymoma  
adult anaplastic oligodendroglioma  
adult central nervous system germ cell tumor
adult pilocytic astrocytoma
adult subependymoma
adult ependymoblastoma
adult pineocytoma
adult pineoblastoma
adult meningeal hemangiopericytoma
adult choroid plexus tumor
adult grade III meningioma
adult giant cell glioblastoma
adult gliosarcoma
adult pineal gland astrocytoma

Study placed in the following topic categories:
Choroid Plexus Neoplasms
Glioblastoma
Astrocytoma
Central Nervous System Diseases
Central Nervous System Neoplasms
Pituitary Neoplasms
Brain Diseases
Hemangiopericytoma
Recurrence
Ependymoma
Brain Neoplasms
Craniopharyngioma
Medulloblastoma
Oligodendroglioma
Meningioma
Glioma
Choroid Plexus neoplasms
Gliosarcoma
Pinealoma
Nervous System Neoplasms

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

ClinicalTrials.gov processed this record on October 07, 2008




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