High Grade Glioma
Conditions
Keywords
childhood anaplastic astrocytoma, childhood glioblastoma multiforme
Brief summary
RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with recurrent/progressive high grade gliomas. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with recurrent/progressive high grade gliomas.
Detailed description
OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in children with recurrent/progressive high grade gliomas, 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 children with recurrent/progressive high grade gliomas. OVERVIEW: This is a single arm, open-label study in which children with recurrent/progressive high grade gliomas 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 for this study.
Interventions
DRUGAntineoplaston therapy (Atengenal + Astugenal)
Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
Sponsors
Burzynski Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma) that is recurrent or progressive or with residual tumor after standard therapy, including radiotherapy * Measurable tumor by MRI scan performed within two weeks prior to study entry * Male or female patients * Children 6 months to 17 years * Performance status: Karnofsky 60-100% * Life expectancy of at least 2 months * WBC greater than 1,500/mm\^3 * Platelet count greater than 50,000/mm\^3 * No evidence of hepatic or renal insufficiency and a total bilirubin and serum creatinine no greater than 2.5 mg/dL and SGOT/SGPT no greater than 5 times upper limit of normal * Must have recovered from adverse effect of previous therapy * At least 8 weeks elapsed since last dose of radiation * At least 4 weeks elapsed since last dose of chemotherapy (6 weeks for nitrosoureas) * Corticosteroids permitted using the smallest dose that is compatible with preservation of optimal neurologic function * Acceptable methods of birth control (in females of child-bearing potential or in sexually active males)during and up to four weeks following completion of study
Exclusion criteria
* Prior A10 and AS2-1 treatment * Severe heart disease * Uncontrolled hypertension * Lung disease * Hepatic failure * Serious active infections, fever or other serious concurrent disease that would interfere with the evaluation of the treatment drug. * Pregnant or nursing * Serious concurrent disease * Concurrent antineoplastic or immunomodulatory agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Objective Response | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Survived | 6 months, 12 months, 24 months | 6 months, 12 months, 24 months overall survival |
Countries
United States
Participant flow
Recruitment details
Nine patients were recruited between April 1994 and August 1997. All study subjects were seen at the Burzynski Clinic in Houston TX
Participants by arm
| Arm | Count |
|---|---|
| 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.
Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal). | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not evaluable | 5 |
Baseline characteristics
| Characteristic | Antineoplaston Therapy |
|---|---|
| Age, Continuous | 9.7 Years |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 7 / 9 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antineoplaston Therapy | Number of Participants With Objective Response | Complete Response | 1 Participants |
| Antineoplaston Therapy | Number of Participants With Objective Response | Partial Response | 1 Participants |
| Antineoplaston Therapy | Number of Participants With Objective Response | Progressive Disease | 2 Participants |
Secondary
Percentage of Participants Who Survived
6 months, 12 months, 24 months overall survival
Time frame: 6 months, 12 months, 24 months
Population: All study subjects receiving any Antineoplaston therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Antineoplaston Therapy | Percentage of Participants Who Survived | 6 months overall survival | 22.2 Percentage of Participants |
| Antineoplaston Therapy | Percentage of Participants Who Survived | 12 months overall survival | 11.1 Percentage of Participants |
| Antineoplaston Therapy | Percentage of Participants Who Survived | 24 months overall survival | 0.0 Percentage of Participants |