Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine
Status: | Terminated |
---|---|
Conditions: | Colorectal Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 10/1/2017 |
Start Date: | August 13, 1997 |
End Date: | December 14, 1997 |
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Small Intestine
Current therapies for Cancer of the Small Intestine provide very limited benefit to the
patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
beneficial in the treatment of Cancer of the Small Intestine.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Cancer of the Small Intestine.
patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
beneficial in the treatment of Cancer of the Small Intestine.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Cancer of the Small Intestine.
Cancer of the Small Intestine patients receive gradually escalating doses of intravenous
Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
Treatment continues up to12 months in the absence of disease progression or unacceptable
toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Cancer of the Small
Intestine, 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 patients with Cancer
of the Small Intestine.
- 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.
Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
Treatment continues up to12 months in the absence of disease progression or unacceptable
toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Cancer of the Small
Intestine, 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 patients with Cancer
of the Small Intestine.
- 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.
DISEASE CHARACTERISTICS:
- Histologically proven incurable and/or metastatic carcinoma of the small intestine
that is unlikely to respond to existing therapy
- Measurable disease by MRI or CT scan
- Tumor must be greater than 2 cm
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:
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
- No renal insufficiency
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No known 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
participation
- Not high medical or psychiatric risk
- No concurrent nonmalignant systemic disease
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulating agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy and recovered
Surgery:
- Recovered from prior surgery
Other:
- Prior cytodifferentiating agents allowed
- No other concurrent antineoplastic agents
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