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Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma (AA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003537
First Posted: January 27, 2003
Last Update Posted: August 24, 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 adults with anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.


Condition Intervention Phase
Adult Brain Tumor 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 Anaplastic Astrocytoma

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; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.


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: 19
Study Start Date: April 1995
Study Completion Date: October 2008
Primary Completion Date: October 2008 (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 an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).
Other Name: A10 (Atengenal); AS2-1 (Astugenal)

Detailed Description:

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in adults with anaplastic astrocytoma 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 anaplastic astrocytoma.

OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma 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. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

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 diagnosis of anaplastic astrocytoma
  • Tumor subtotally resected or biopsied prior to therapy
  • Evidence of residual tumor by MRI scan performed within two weeks prior to study entry
  • No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 2 months

Hematopoietic:

  • WBC at least 1,500/mm^3
  • Platelet count at least 50,000/mm^3
  • Hemoglobin at least 10 g/dL

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 renal failure

Cardiovascular:

  • No prior congestive heart failure
  • No coronary artery disease
  • No myocardial infarction within the past year
  • No angina requiring medication
  • No uncontrolled hypertension

Pulmonary:

  • No moderate to severe chronic obstructive pulmonary disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No active infection
  • No other concurrent serious disease
  • No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • No prior myelosuppressive chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

  • No prior myelosuppressive radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from any prior surgery

Other:

  • No prior cytodifferentiating agents
  • No prior antineoplaston therapy
  • No other concurrent antineoplastic agents
  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): NCT00003537


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:
Publications:
Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A. A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Newly-Diagnosed Anaplastic Astrocytoma Final Report (Protocol BT-08). Cancer and Clinical Oncology 4: 28-38, 2015. DOI: http://dx.doi.org/10.5539/cco.v4n1p28

Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003537     History of Changes
Other Study ID Numbers: CDR0000066585
BC-BT-8 ( Other Identifier: Burzynski Research Institute, Inc. )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: October 25, 2016
Results First Posted: February 20, 2017
Last Update Posted: August 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Burzynski Research Institute:
adult anaplastic astrocytoma

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