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Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Waldenstrom's Macroglobulinemia


OBJECTIVES:

- Determine the antitumor effects of low-dose beta alethine in patients with
Waldenstrom's macroglobulinemia.

- Determine the effects of this drug on anemia, performance status, and disease symptoms
in these patients.

- Determine the effects of this drug on the immune system of these patients.

- Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive beta alethine subcutaneously on days 1, 15, 29, 43, 57, and 71. Courses
repeat every 85 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 13-37 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Confirmed diagnosis of Waldenstrom's macroglobulinemia

- Urine or serum protein electrophoresis showing a measurable monoclonal spike

- Indolent disease not yet requiring therapy allowed

- Positive delayed-type hypersensitivity (DTH) response

- Induration greater than 2 mm for at least 1 antigen

- 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:

- Neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin at least 10 g/dL

Hepatic:

- Albumin at least 3.5 g/dL

- 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 EKG

- No uncontrolled angina

- No heart failure

- No arrhythmia

Other:

- Adequate nutritional intake as evidenced by total protein at least 60 g/L

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No concurrent gastrointestinal bleed

- No active bacterial infections such as abscess or with fistulae

- HIV negative

- No other concurrent non-malignant disease that would preclude study

- No history of alcoholism, drug addiction, or psychotic disorders that would preclude
follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- More than 4 weeks since prior immunotherapy

- More than 4 weeks since prior cytokines

- More than 4 weeks since prior plasmapheresis or plasma exchange

- No prior stem cell or bone marrow transplant

Chemotherapy:

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or
high-dose carboplatin)

- No prior intensive chemotherapy with stem cell support

Endocrine therapy:

- More than 4 weeks since prior corticosteroids

- No concurrent corticosteroids

Radiotherapy:

- More than 4 weeks since prior radiotherapy involving more than 25% of bone marrow

Surgery:

- Recovered from any prior surgery

- No prior organ transplant

Other:

- No other concurrent investigational agent

- No concurrent immunosuppressants

- No concurrent anti-inflammatory agents including aspirin and non-steroidal
anti-inflammatory agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Suzin Mayerson, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

LifeTime Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000069494

NCT ID:

NCT00041379

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • Waldenström macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia

Name

Location

Victory Over CancerRockville, Maryland  20852