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.
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with recurrent or progressing multiple myeloma after standard first line
- 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
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Histologically and biochemically confirmed recurrent or progressing multiple myeloma
that is unlikely to respond to existing therapy, including surgery, radiotherapy, and
- 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
- 18 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 and SGPT no greater than 5 times upper limit of normal
- No hepatic insufficiency
- Creatinine no greater than 2.5 mg/dL
- No renal problems
- No renal conditions that contraindicate high dosages of sodium
- No chronic heart failure
- No uncontrolled hypertension
- No history of congestive heart failure
- No other cardiovascular conditions that contraindicate high dosages of sodium
- No severe lung disease, such as chronic obstructive pulmonary disease
- 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:
- 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 (patients with multiple
tumors who have received radiotherapy to some, but not all, tumors may be admitted
earlier than 8 weeks)
- Must be recovered from prior surgery
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy