Beta Alethine in Treating Patients With Myeloma

Sponsor

LifeTime Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00006466

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition	Drug: beta alethine	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

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 :

Aug 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Emory Clinic	Atlanta	Georgia	United States	30322
2	Victory Over Cancer	Rockville	Maryland	United States	20852
3	St. Vincents Comprehensive Cancer Center	New York	New York	United States	10011