Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Lymphoma

Lymphoma, Non-Hodgkin

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Lymphosarcoma

Chronic Lymphocytic Leukemia

Follicular Lymphoma

Marginal Zone Lymphoma

beta alethine

Suzin Mayerson, PhD

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 low-grade lymphoma.

OBJECTIVES:

* Determine the antitumor effects of low-dose beta-alethine in patients with low grade B-cell lymphoma.
* Assess the effects of this regimen on delayed-type hypersensitivity in these patients.
* Assess the safety of this regimen in this patient population.

OUTLINE: This is an multicenter study.

Patients receive low-dose beta-alethine subcutaneously once every 2 weeks for a total of 6 doses in the absence of unacceptable toxicity. Patients with no evidence of tumor progression may receive additional courses of therapy.

Patients are followed for 2 weeks from the last dose or for a minimum of 30 days if they withdraw due to an adverse event.

PROJECTED ACCRUAL: Approximately 13-37 patients will be accrued for this study.

Beta Alethine in Treating Patients With Low-Grade Lymphoma

Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With B-Cell Lymphoma

LifeTime Pharmaceuticals

Heart and Blood Diseases

Waldenstrom Macroglobulinemia

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

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 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.

Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia

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

Multiple Myeloma

Plasmacytoma

Monoclonal Gammopathy of Undetermined Significance

Precancerous Conditions

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.

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.

Beta Alethine in Treating Patients With Myeloma

Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Beta Alethine in Treating Patients With Low-Grade Lymphoma	NCT00007839	Lymphoma	beta alethine	18 Years -	National Cancer Institute (NCI)
Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia	NCT00041379	Lymphoma	beta alethine	18 Years -	National Cancer Institute (NCI)
Beta Alethine in Treating Patients With Myeloma	NCT00006466	Multiple Myelom... Precancerous Co...	beta alethine	18 Years -	National Cancer Institute (NCI)
Beta Alethine in Treating Patients With Myeloma	NCT00006466	Multiple Myelom... Precancerous Co...	beta alethine	18 Years -	National Cancer Institute (NCI)
Beta Alethine in Treating Patients With Low-Grade Lymphoma	NCT00007839	Lymphoma	beta alethine	18 Years -	National Cancer Institute (NCI)
Beta Alethine in Treating Patients With Low-Grade Lymphoma	NCT00007839	Lymphoma	beta alethine	18 Years -	National Cancer Institute (NCI)

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