Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme
Antineoplaston therapy (Atengenal + Astugenal)
Astrocytoma+7
+ Glioma
+ Neoplasms
Treatment Study
Summary
Study start date: March 14, 1995
Actual date on which the first participant was enrolled.OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with newly diagnosed 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 newly diagnosed Glioblastoma Multiforme, 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 newly diagnosed 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed Glioblastoma Multiforme Subtotal resection or biopsy only of tumor Measurable tumor by MRI scan performed within two weeks prior to study entry Tumor must be at least 5 mm No brain stem tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 4 months Hematopoietic: WBC at least 1,500/mm^3 Platelet count at least 50,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: No hepatic failure Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL No history of renal conditions that would contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension Other: Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent immunomodulatory agents Chemotherapy: No prior chemotherapy No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids for cerebral edema allowed Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Recovered from any prior surgery
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location