Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme

Burzynski Research Institute40 enrolled

Overview

RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.

OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with residual/recurrent/progressed Glioblastoma Multiforme 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 (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme following initial therapy, including radiotherapy, 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 (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme. * 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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme of the Brain

Interventions

Antineoplaston therapy (Atengenal + Astugenal)DRUG

Adults with a residual/recurrent/progressive Glioblastoma Multiforme 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy) * Measurable disease by MRI or CT scan * Brain stem tumor is excluded * Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2,000/mm3 * Platelet count at least 50,000/mm3 Hepatic: * No liver failure * Bilirubin no greater than 2.5 mg/dL * SGOT/SGPT no greater than 5 times upper limit Renal: * No history of renal conditions that contraindicate high dosages of sodium * Creatinine no greater than 2.5 mg/dL Cardiovascular: * No uncontrolled hypertension * No history of congestive heart failure * No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No serious lung disease (e.g., severe COPD) Other: * Not pregnant or nursing * Fertile patients must use adequate contraception during and for 4 weeks after study * No active infection * No other serious medical or psychiatric conditions PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since immunotherapy * No concurrent immunomodulating agents Chemotherapy: * See Disease Characteristics * At least 4 weeks since chemotherapy (unless radiologically proven progression) * At least 6 weeks since nitrosoureas Endocrine therapy: * Corticosteroids allowed Radiotherapy: * See Disease Characteristics * At least 8 weeks since radiotherapy (unless radiologically proven progression) Surgery: * Recovered from prior surgery Other: * No prior antineoplaston therapy * Prior cytodifferentiating agent allowed

Locations (1)

Burzynski Clinic

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Percentage of Participants Who Survived

6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

Time frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

Data from ClinicalTrials.gov

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