Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme
Antineoplaston therapy (Atengenal + Astugenal)
Astrocytoma+7
+ Glioma
+ Neoplasms
Treatment Study
Summary
Study start date: March 14, 1996
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 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.
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 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
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