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.

Condition	Treatment or Intervention	Phase
stage IV adrenocortical carcinoma recurrent adrenocortical carcinoma	Drug: antineoplaston A10  Drug: antineoplaston AS2-1  Procedure: alternative product therapy  Procedure: biological response modifier therapy  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: differentiation therapy	Phase II

Further Study Details: 

OBJECTIVES:

• 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 second year.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Ages Eligible for Study:  1 Year and above,  Genders Eligible for Study:  Both

Criteria

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:

• 1 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

Texas
      Burzynski Clinic, Houston,  Texas,  77055-6330,  United States; Recruiting

Study chairs or principal investigators

Stanislaw R. Burzynski, MD, PhD,  Study Chair,  Burzynski Research Institute   

Study ID Numbers:  CDR0000066485; BC-AD-2; NCT00003453
Record last reviewed:  August 2003
Last Updated:  February 9, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003453
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08