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.

Condition	Treatment or Intervention	Phase
Lymphoma	Procedure: biological response modifier therapy  Procedure: non-specific immune-modulator therapy  Drug: beta alethine	Phase I Phase II

Further Study Details: 

OBJECTIVES: I. Determine the antitumor effects of low-dose beta-alethine in patients with low grade B-cell lymphoma. II. Assess the effects of this regimen on delayed-type hypersensitivity in these patients. III. Assess the safety of this regimen in this patient population.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• 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

[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 terminology.]

--Prior/Concurrent Therapy--

• Biologic therapy: Prior bone marrow transplantation allowed; At least 4 weeks since prior immunotherapy or cytokines
• Chemotherapy: 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)
• Endocrine therapy: No concurrent corticosteroids
• Radiotherapy: At least 4 weeks since prior radiotherapy to more than 25% of bone marrow
• Surgery: Recovered from prior surgery; No prior solid organ transplantation
• Other: No concurrent antiinflammatory agents including aspirin, or over the counter or prescription nonsteroidal antiinflammatory drugs; No concurrent immunosuppressive agents; No other concurrent investigational agents

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 50-100%
• Life expectancy: At least 4 months
• Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL
• Hepatic: 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)
• Renal: Creatinine no greater than 2.0 mg/dL; Calculated creatinine clearance at least 60 mL/min
• Cardiovascular: No uncontrolled angina, heart failure, or arrhythmia; No acute changes on EKG
• Other: 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 study

Maryland
      Victory Over Cancer, Rockville,  Maryland,  20852,  United States

Study chairs or principal investigators

Suzin Mayerson,  Study Chair,  LifeTime Pharmaceuticals   

Study ID Numbers:  CDR0000068279; LIFETIME-LTP-99-02; NCI-V00-1628; LIFETIME-IRB-0300202
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00007839
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08