Meningioma
Conditions
Keywords
adult meningioma, recurrent adult meningioma
Brief summary
RATIONALE: Current therapies for adults with meningioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with meningioma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with meningioma.
Detailed description
OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in adults with meningima 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 meningima. OVERVIEW: This is a single arm, open-label study in which adults with meningioma 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
Interventions
DRUGAntineoplaston therapy (Atengenal + Astugenal)
Adults with a meningioma 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
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed meningioma that has progressed or recurred following surgical resection and radiotherapy * Evidence of residual tumor by MRI scan performed within two weeks prior to study entry 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 2000/mm3 * Platelet count at least 50,000/mm3 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 chronic heart failure * No uncontrolled hypertension * No history of congestive heart failure * No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No serious lung disease, such as chronic obstructive pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study * No active infection * No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunomodulatory agents Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No concurrent antineoplastic agents Endocrine therapy: * Concurrent corticosteroids allowed * At least 4 weeks since prior therapy with mifepristone and recovered Radiotherapy: * At least 8 weeks since prior radiotherapy and recovered Surgery: * Recovered from prior surgery Other: * Prior cytodifferentiating agent allowed * No prior antineoplaston therapy
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; 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 eight weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions. |
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
Three patients were recruited between June 1996 and March 2004. 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): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal). | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not evaluable | 1 |
Baseline characteristics
| Characteristic | Antineoplaston Therapy |
|---|---|
| Age, Continuous | 41.8 Years |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 3 / 3 |
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; 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 eight weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Antineoplaston Therapy | Number of Participants With Objective Response | Stable Disease | 2 Participants |
| Antineoplaston Therapy | Number of Participants With Objective Response | Objective Response | 0 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 | 66.7 Percentage of Participants |
| Antineoplaston Therapy | Percentage of Participants Who Survived | 12 months overall survival | 33.3 Percentage of Participants |
| Antineoplaston Therapy | Percentage of Participants Who Survived | 24 months overall survival | 33.3 Percentage of Participants |