Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/17/2018 |
| Start Date: | March 14, 1996 |
| End Date: | June 21, 2003 |
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme
RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the
patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
beneficial in the treatment of brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive
Glioblastoma Multiforme.
patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
beneficial in the treatment of brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive
Glioblastoma Multiforme.
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.
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.
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
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