Beta Alethine in Treating Patients With Myeloma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 myeloma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LifeTime Pharmaceuticals
• Treatments: Cysteamine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven myeloma

• Multiple myeloma

• Indolent myeloma with slowly progressive bone pathology

• Smoldering myeloma with no bone pathology but a progressive increase in M-protein

• Solitary myeloma OR

• Diagnosis of evolving monoclonal gammopathy of undetermined significance with increasing M-protein or decreasing hemoglobin level

• Measurable M-protein or Bence Jones protein

• Indolent disease not requiring therapy allowed

• No clinical signs or evidence of active brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 50-100%

Life expectancy:

• At least 4 months

Hematopoietic:

• See Disease Characteristics

• Neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 2.0 mg/dL

• Transaminases no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No acute changes on electrocardiogram

• No uncontrolled angina, heart failure, or arrhythmia

Other:

• Adequate nutritional status (total protein at least 60.0 g/L, albumin at least 35 g/L)

• HIV negative

• No AIDS

• No active bacterial infection (e.g., abscess) or with fistula

• No history of alcoholism, drug addiction, or psychotic disorders that would preclude study

• No other nonmalignant disease that would preclude study

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy or cytokines

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin)

Endocrine therapy:

• No concurrent corticosteroids

Radiotherapy:

• No prior radiotherapy to greater than 25% of bone marrow

Surgery:

• Recovered from any prior surgery

• No prior solid organ transplantation

Other:

• No other concurrent investigational agent

• No concurrent immunosuppressive agents

• No concurrent anti-inflammatory agents, including aspirin or over-the-counter or prescription nonsteroidal anti-inflammatory drugs