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Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003472
First Posted: January 27, 2003
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Burzynski Research Institute
  Purpose

RATIONALE: Current therapies for adult recurrent/progressive oligodendrogliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adult recurrent/progressive oligodendrogliomas.


Condition Intervention Phase
Oligodendroglioma, Adult Drug: Antineoplaston therapy (Atengenal + Astugenal) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Oligodendroglioma

Resource links provided by NLM:


Further study details as provided by Burzynski Research Institute:

Primary Outcome Measures:
  • Number of Participants With Objective Response [ Time Frame: 12 months ]
    Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.


Secondary Outcome Measures:
  • Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ]
    6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival


Enrollment: 13
Study Start Date: May 1996
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Other Name: A10 (Atengenal); AS2-1 (Astugenal)

Detailed Description:

OVERVIEW: This is a single arm, open-label study in which adults with recurrent/progressive oligodendrogliomas receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in adults with recurrent/progressive oligodendrogliomas, as measured by an objective response to therapy (complete response, partial response or stable disease).
  • To determine the safety and tolerance of Antineoplaston therapy in adults with recurrent/progressive oligodendrogliomas.
  • To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed incurable oligodendroglioma that progressed during or is recurrent or residual after initial therapy, including radiotherapy and/or chemotherapy
  • Measurable tumor by MRI scan performed within two weeks prior to study entry
  • Tumor must be at least 5 mm
  • No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • 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 (e.g., chronic obstructive pulmonary disease)

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

  • Concurrent corticosteroids allowed

Radiotherapy:

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

Surgery:

  • Recovered from any prior surgery

Other:

  • No prior antineoplaston therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003472


Locations
United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Investigators
Principal Investigator: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information

Additional Information:
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003472     History of Changes
Other Study ID Numbers: CDR0000066509
BC-BT-17 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: August 1, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Burzynski Research Institute:
Recurrent/progressive adult oligodendroglioma
Recurrent/progressive adult anaplastic oligodendroglioma

Additional relevant MeSH terms:
Oligodendroglioma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue