Purpose:
Current therapies for Recurrent or Refractory Waldenstrom's Macroglobulinemia provide very
limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest
that it may prove beneficial in the treatment of Recurrent or Refractory Waldenstrom's
Macroglobulinemia.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Recurrent or Refractory Waldenstrom's
Macroglobulinemia.
Study summary:
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 physical examination,
radiologic studies, and bone marrow biopsies as necessary, 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.
Criteria:
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