Beta Alethine in Treating Patients With Myeloma
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition |
Drug: beta alethine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma |
| Study Start Date: | August 2000 |
OBJECTIVES:
- Determine the antitumor effects of low-dose beta alethine in patients with myeloma or progressive monoclonal gammopathy of undetermined significance.
- Determine the effects of this regimen on anemia, performance status, pain, and delayed-type hypersensitivity (immune response) in these patients.
- Determine the safety of this regimen in these patients.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Georgia | |
| Emory Clinic | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Victory Over Cancer | |
| Rockville, Maryland, United States, 20852 | |
| United States, New York | |
| St. Vincents Comprehensive Cancer Center | |
| New York, New York, United States, 10011 | |
| Study Chair: | Suzin Mayerson, PhD | LifeTime Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006466 History of Changes |
| Other Study ID Numbers: | CDR0000068280, LIFETIME-LTP-99-01, LIFETIME-IRB-0300203 |
| Study First Received: | November 6, 2000 |
| Last Updated: | February 1, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
monoclonal gammopathy of undetermined significance isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Additional relevant MeSH terms:
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Precancerous Conditions Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Cysteamine Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013