Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
| Status: | Terminated |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/17/2018 |
| Start Date: | May 1996 |
| End Date: | September 2007 |
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Oligodendroglioma
RATIONALE: Current therapies for adult recurrent/progressive oligodendrogliomas provide very
limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest
that it may prove beneficial in the treatment of childhood brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on adult recurrent/progressive oligodendrogliomas.
limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest
that it may prove beneficial in the treatment of childhood brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on adult recurrent/progressive oligodendrogliomas.
OVERVIEW: This is a single arm, open-label study in which adults with recurrent/progressive
oligodendrogliomas 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 with recurrent/progressive
oligodendrogliomas, 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
recurrent/progressive oligodendrogliomas.
- 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.
oligodendrogliomas 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 with recurrent/progressive
oligodendrogliomas, 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
recurrent/progressive oligodendrogliomas.
- 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 or cytologically confirmed incurable oligodendroglioma that progressed
during or is recurrent or residual after initial therapy, including radiotherapy
and/or chemotherapy
- Measurable tumor by MRI scan performed within two weeks prior to study entry
- Tumor must be at least 5 mm
- No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
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 severe heart disease
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of
sodium
Pulmonary:
- No severe lung disease (e.g., chronic obstructive pulmonary disease)
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
participation
- No serious active infections
- No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 4 weeks since prior immunotherapy
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 8 weeks since prior radiotherapy
Surgery:
- Recovered from any prior surgery
Other:
- No prior antineoplaston therapy
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