Antineoplaston Therapy in Treating Patients With Brain Tumors

Phase II Study Of Antineoplastons A10 And AS2-1 In Patients With Brain Tumors.

RATIONALE: Current therapies for adults with persistent or recurrent brain tumors 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 persistent or recurrent brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with persistent or recurrent brain tumors.

Study Overview

• Status: Completed
• Conditions: Refractory Brain Tumors
• Intervention / Treatment: Drug: Antineoplaston therapy (Atengenal + Astugenal)

Detailed Description

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in adults with persistent or recurrent brain tumors 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 persistent or recurrent brain tumors.

OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent brain tumors 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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77055-6330
      • Burzynski Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed brain tumor (except brain stem locations) that is unlikely to respond to existing therapy and for which no curative therapy exists
• Evidence of persistent or recurrent brain tumor by MRI scan performed within two weeks prior to study entry
• Tumor must be at least 5 mm
• Ineligible for other Burzynski Research Institute, Inc. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).; Other Names: A10 (Atengenal); AS2-1 (Astugenal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Objective Response	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 8 weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Survived	6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival	6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Collaborators and Investigators

• Sponsor: Burzynski Research Institute

Publications and helpful links

General Publications

• Burzynski SR, Janicki TJ, Burzynski GS. A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Primary Brain Tumors-Final Report (Protocol BT-09). Journal of Cancer Therapy 6(12): 1063-1074, 2015. DOI: 10.4236/jct.2015.612116

Helpful Links

• Burzynski Research Institute
• Burzynski Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 1996
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Glioma; Anaplastic astrocytoma; Glioblastoma multiforme; Astrocytoma; Tectal glioma; Anaplastic astrocytoma/Mixed; Astrocytoma/Pilocytic; Brainstem glioma; Neurocytoma; Primitive neuroectodermal tumor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: CDR0000066489; BC-BT-9 (Other Identifier: Burzynski Research Institute, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No