RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the
laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating
patients with stage IV adrenal gland cancer.
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with stage IV adrenal gland carcinoma.
- Determine the tolerance to and side effects of this regimen in these patients.
- Determine the response in patients treated with this regimen.
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and
antineoplaston AS2-1 IV over a minimum of 1 hour 6 times daily until the maximum tolerated
dose is reached.
Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Patients are followed every 2 months for the first year and then every 3 months for the
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- 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
- 6 months and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
- No severe heart disease
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of
- No severe lung disease
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
- No serious active infections or fever
- No other concurrent serious disease
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulating agents
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent antineoplastic agents
- Concurrent corticosteroids allowed
- At least 8 weeks since prior radiotherapy and recovered
- Recovered from any prior operative procedure
- No prior antineoplaston therapy
- Prior cytodifferentiating agent allowed