Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine
Sponsored by Burzynski Research Institute
About this trial
Last updated 8 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 28 years ago
What is this trial about?
What are the Participation Requirements?
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