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Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute
ClinicalTrials.gov Identifier:
NCT00003475
First received: November 1, 1999
Last updated: October 26, 2016
Last verified: October 2016
  Purpose

RATIONALE: Current therapies for adults with primary malignant brain tumors that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with primary malignant brain tumors that have not responded to standard therapy.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with primary malignant brain tumors that have not responded to standard therapy.


Condition Intervention Phase
Malignant Brain Tumors
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Primary Malignant Brain Tumors

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival


Enrollment: 40
Study Start Date: February 1996
Study Completion Date: May 2011
Primary Completion Date: May 2011 (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 primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Other Name: A10 (Atengenal); AS2-1 (Astugenal)

Detailed Description:

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in patients with primary malignant brain tumors that have not responded to standard therapy, 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 patients with a primary malignant brain tumor.

OVERVIEW: This is a single arm, open-label study in which adults with malignant brain tumors that have not responded to standard therapy 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

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed incurable adult primary malignant brain tumor
  • Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry
  • Must have received and failed standard therapy
  • 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:

  • Hematological function normal
  • WBC at least 2000/mm^3
  • Platelet count at least 50,000/mm^3

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No serious lung disease, such as 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 medical or psychiatric illness that would preclude study treatment
  • No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 4 weeks since prior chemotherapy, except in patients with disease progression during initial therapy
  • At least 6 weeks since prior nitrosoureas, except in patients with disease progression during initial therapy
  • No concurrent antineoplastic agents

Endocrine therapy:

  • Corticosteroids allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 8 weeks since prior radiotherapy, except in patients with disease progression during initial therapy

Surgery:

  • At least 4 weeks since prior surgery, except in patients with disease progression during initial therapy

Other:

  • Recovered from prior therapy
  • Cytodifferentiating agents allowed
  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: NCT00003475

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. A phase II study of antineoplastons A10 and AS2-1 in adult patients with recurrent glioblastoma multiforme: Final report (protocol BT-21). Journal of Cancer Therapy 5:946-956, 2014. DOI: http://dx.doi.org/10.4236/jct.2014.510100

Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003475     History of Changes
Other Study ID Numbers: CDR0000066512  BC-BT-21 
Study First Received: November 1, 1999
Results First Received: October 26, 2016
Last Updated: October 26, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Burzynski Research Institute:
adult glioblastoma multiforme
adult anaplastic astrocytoma
adult anaplastic astrocytoma/Mixed

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

ClinicalTrials.gov processed this record on January 17, 2017