RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the
immune system and stop cancer cells from growing.
PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients
who have low-grade lymphoma.
- Determine the antitumor effects of low-dose beta-alethine in patients with low grade
- Assess the effects of this regimen on delayed-type hypersensitivity in these patients.
- Assess the safety of this regimen in this patient population.
OUTLINE: This is an multicenter study.
Patients receive low-dose beta-alethine subcutaneously once every 2 weeks for a total of 6
doses in the absence of unacceptable toxicity. Patients with no evidence of tumor
progression may receive additional courses of therapy.
Patients are followed for 2 weeks from the last dose or for a minimum of 30 days if they
withdraw due to an adverse event.
PROJECTED ACCRUAL: Approximately 13-37 patients will be accrued for this study.
- Histologically confirmed low grade B-cell lymphoma
- Measurable residual disease after maximal response to prior chemotherapy OR
- Indolent disease not yet requiring therapy
- No congenital immunodeficiency associated lymphoma
- No primary lymphoma of the brain
- No active brain involvement or leptomeningeal disease NOTE: A new classification
scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of
"indolent" or "aggressive" lymphoma will replace the former terminology of "low",
"intermediate", or "high" grade lymphoma. However, this protocol uses the former
- 18 and over
- Karnofsky 50-100%
- At least 4 months
- Neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 10 g/dL
- Bilirubin less than 2.0 mg/dL
- SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5
times ULN if liver metastases present)
- Creatinine no greater than 2.0 mg/dL
- Calculated creatinine clearance at least 60 mL/min
- No uncontrolled angina, heart failure, or arrhythmia
- No acute changes on EKG
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No AIDS
- Adequate nutritional status (total protein at least 60.0 g/L)
- No active bacterial infections (e.g., abscess or with fistula)
- No nonmalignant disease that would preclude study
- No history of alcoholism, drug addiction, or psychotic disorders that would preclude
PRIOR CONCURRENT THERAPY:
- Prior bone marrow transplantation allowed
- At least 4 weeks since prior immunotherapy or cytokines
- See Disease Characteristics
- Prior intensive chemotherapy with stem cell support allowed
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or
high dose carboplatin)
- No concurrent corticosteroids
- At least 4 weeks since prior radiotherapy to more than 25% of bone marrow
- Recovered from prior surgery
- No prior solid organ transplantation
- No concurrent antiinflammatory agents including aspirin, or over the counter or
prescription nonsteroidal antiinflammatory drugs
- No concurrent immunosuppressive agents
- No other concurrent investigational agents