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Home > "B" Clinical Trials Conditions > Beta Alethine in Treating Patients With Myeloma  Beta Alethine in Treating Patients With Myeloma
Beta Alethine in Treating Patients With Myeloma
For Condition: isolated plasmacytoma of bone,stage 3 multiple myeloma,monoclonal gammopathy of undetermined significance,stage 1 multiple myeloma,stage 2 multiple myeloma,refractory plasma cell neoplasm,extramedullary plasmacytoma
Status: No longer recruiting
Sponsor(s): LifeTime Pharmaceuticals ,
Synopsis: 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.
Details: OBJECTIVES: I. Determine the antitumor effects of low-dose beta alethine in patients with myeloma or progressive monoclonal gammopathy of undetermined significance. II. Determine the effects of this regimen on anemia, performance status, pain, and delayed-type hypersensitivity (immune response) in these patients. III. Determine the safety of this regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive beta alethine subcutaneously every 2 weeks for 6 doses. At day 85, patients may receive an additional 12-week course of therapy in the absence of disease progression or unacceptable toxicity. Patients with an apparent complete response receive additional courses. Patients are followed for 2 weeks. PROJECTED ACCRUAL: A total of 13-37 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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/mm3; Platelet count at least 100,000/mm3; 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SuzinMayerson, Study Chair, LifeTime Pharmaceuticals
St. Vincents Comprehensive Cancer Center
New York City, New York, 10011
United States
Victory Over Cancer
Rockville, Maryland, 20852
United States
Emory Clinic
Atlanta, Georgia, 30322
United States
Additional Information:
Study ID Numbers: CDR0000068280; LIFETIME-IRB-0300203,LIFETIME-LTP-99-01
Study Start Date: August 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006466
Other Refractory Plasma Cell Neoplasm Studies:
1. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
2. Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
3. Combination Chemotherapy With or Without PSC 833 in Treating Patients With Relapsed or Refractory Multiple Myeloma
4. Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Tandem Autologous Stem Cell Transplantation With or Without Maintenance Therapy After the Second Transplantation Compared With Autologous Stem Cell Transplantation Followed By Matched Sibling Allogeneic Stem Cell Transplantation in Patients With Stage II or Stage III Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other New York Clinical Trials
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Beta Alethine in Treating Patients With Myeloma
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