Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia

Recurrent or Refractory Waldenstrom's Macroglobulinemia patients receive gradually escalating
doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum
tolerated dose is reached. Treatment continues up to 12 months in the absence of disease
progression or unacceptable toxicity.

OBJECTIVES:

- To determine the efficacy of Antineoplaston therapy in patients with Recurrent or
Refractory Waldenstrom's Macroglobulinemia, 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
Recurrent or Refractory Waldenstrom's Macroglobulinemia.

- 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 recurrent or progressive Waldenstrom's macroglobulinemia that
is unlikely to respond to existing therapy, including surgery, radiotherapy, and
chemotherapy

- Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan

- Must have received and failed at least one standard first-line therapy (e.g.,
corticosteroid/alkylator combination)

- Biochemical evidence of Waldenstrom's macroglobulinemia

- Abnormal proteins in serum and urine

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2000/mm3

- Platelet count at least 50,000/mm3

Hepatic:

- No hepatic insufficiency

- Bilirubin no greater than 2.5 mg/dL

- SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

- No renal insufficiency

- Creatinine no greater than 2.5 mg/dL

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No uncontrolled hypertension

- No history of congestive heart failure

- No history of other cardiovascular conditions that contraindicate high dosages of
sodium

Pulmonary:

- No serious 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 active infection

- No non-malignant systemic disease

- Not a high medical or psychiatric risk

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy

- No concurrent immunomodulating agent

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks (6 weeks since nitrosoureas) since prior chemotherapy

- No concurrent antineoplastic agents

Endocrine therapy:

- See Disease Characteristics

- Concurrent corticosteroids allowed

Radiotherapy:

- See Disease Characteristics

- At least 8 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

- Recovered from prior surgery

Other:

- No prior antineoplastons

- Prior cytodifferentiating agents allowed