Adult Brain Tumor
Conditions
Keywords
adult anaplastic astrocytoma
Brief summary
RATIONALE: Current therapies for adults with anaplastic astrocytoma 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 anaplastic astrocytoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.
Detailed description
OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in adults with anaplastic astrocytoma 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 anaplastic astrocytoma. OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma 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 an anaplastic astrocytoma 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 or cytologically confirmed diagnosis of anaplastic astrocytoma * Tumor subtotally resected or biopsied prior to therapy * Evidence of residual tumor by MRI scan performed within two weeks prior to study entry * No brain stem tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 2 months Hematopoietic: * WBC at least 1,500/mm\^3 * Platelet count at least 50,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT and SGPT no greater than 5 times upper limit of normal * No hepatic failure Renal: * Creatinine no greater than 2.5 mg/dL * No renal failure Cardiovascular: * No prior congestive heart failure * No coronary artery disease * No myocardial infarction within the past year * No angina requiring medication * No uncontrolled hypertension Pulmonary: * No moderate to severe chronic obstructive pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * No active infection * No other concurrent serious disease * No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy * No concurrent immunomodulating agents Chemotherapy: * No prior myelosuppressive chemotherapy Endocrine therapy: * Concurrent corticosteroids for cerebral edema allowed Radiotherapy: * No prior myelosuppressive radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from any prior surgery Other: * No prior cytodifferentiating agents * No prior antineoplaston therapy * No other concurrent antineoplastic 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; 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, 36 months, 48 months, 60 months | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival |
Countries
United States
Participant flow
Recruitment details
Nineteen patients were recruited between April 1995 and October 2008. 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 residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal). | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not evalauable | 1 |
Baseline characteristics
| Characteristic | Antineoplaston Therapy |
|---|---|
| Age, Continuous | 44.0 Years |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 19 |
| serious Total, serious adverse events | 11 / 19 |
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 | Partial Response | 1 Participants |
| Antineoplaston Therapy | Number of Participants With Objective Response | Stable Disease | 5 Participants |
| Antineoplaston Therapy | Number of Participants With Objective Response | Complete Response | 3 Participants |
| Antineoplaston Therapy | Number of Participants With Objective Response | Progressive Disease | 9 Participants |
Secondary
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
Population: All study subjects receiving any Antineoplaston therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Antineoplaston Therapy | Percentage of Participants Who Survived | 24 months overall survival | 36.8 Percentage of participants |
| Antineoplaston Therapy | Percentage of Participants Who Survived | 36 months overall survival | 26.3 Percentage of participants |
| Antineoplaston Therapy | Percentage of Participants Who Survived | 48 months overall survival | 26.3 Percentage of participants |
| Antineoplaston Therapy | Percentage of Participants Who Survived | 60 months overall survival | 21.1 Percentage of participants |
| Antineoplaston Therapy | Percentage of Participants Who Survived | 6 months overall survival | 68.4 Percentage of participants |
| Antineoplaston Therapy | Percentage of Participants Who Survived | 12 months overall survival | 52.6 Percentage of participants |