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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

CDR0000066566

Status

Terminated

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 99 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 28 years ago

What is this trial about?

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.

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

Locations

Location

Status