Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV adrenal
gland cancer 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 Stage IV adrenal
gland cancer, 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 Stage
IV adrenal gland cancer.

- 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 confirmed stage IV adrenal gland carcinoma that is unlikely to respond
to existing therapy and for which no curative therapy exists

- Measurable disease by MRI or CT scan

- Tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in
the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the
largest diameter for other localizations

PATIENT CHARACTERISTICS:

Age:

- 6 months 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

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study
participation

- No serious active infections or fever

- No other concurrent serious disease

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

- No concurrent antineoplastic agents

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Recovered from any prior operative procedure

Other:

- No prior antineoplaston therapy

- Prior cytodifferentiating agent allowed