Beta Alethine in Treating Patients With Myeloma - Full Text View

Sponsor:	LifeTime Pharmaceuticals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006466

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 I Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2000

Detailed Description:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006466

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

Sponsors and Collaborators

LifeTime Pharmaceuticals

Investigators

Study Chair:

Suzin Mayerson, PhD

LifeTime Pharmaceuticals

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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
Disease
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Precancerous Conditions
Pathologic Processes
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 February 12, 2012