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 recurrent or progressive multiple myeloma after treatment.

Condition	Treatment or Intervention	Phase
refractory plasma cell neoplasm stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma	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 recurrent or progressing multiple myeloma after standard first line therapy.
• Describe response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 3 months in the absence of toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months for the first year and 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:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically and biochemically confirmed recurrent or progressing multiple myeloma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy
• At least one standard first line therapy failure
• No localized plasmacytoma or plasmacytosis limited to the bone marrow
• Evidence of tumor by MRI or CT scan
• Presence of myeloma proteins in serum and urine, including Bence-Jones proteins

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:

• Bilirubin no greater than 2.5 mg/dL
• SGOT and SGPT no greater than 5 times upper limit of normal
• No hepatic insufficiency

Renal:

• Creatinine no greater than 2.5 mg/dL
• No renal problems
• No renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No chronic heart failure
• No uncontrolled hypertension
• No history of congestive heart failure
• No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No severe 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
• No serious medical or psychiatric disorders
• No active infections

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 (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks)

Surgery:

• Must be recovered from prior surgery

Other:

• Prior cytodifferentiating agent allowed
• No prior antineoplaston therapy

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:  CDR0000066554; BC-MM-2; NCT00003511
Record last reviewed:  December 2002
Last Updated:  February 7, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003511
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08