Beta Alethine in Treating Patients With Low-Grade Lymphoma

Sponsor

LifeTime Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00007839

Collaborator

(none)

Location

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 low-grade lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: beta alethine	Phase 1/Phase 2

Detailed Description

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.

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 B-Cell Lymphoma

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 confirmed low grade B-cell lymphoma
Measurable residual disease after maximal response to prior chemotherapy OR
Indolent disease not yet requiring therapy
No congenital immunodeficiency associated lymphoma
No primary lymphoma of the brain
No active brain involvement or leptomeningeal disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

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:

Bilirubin less than 2.0 mg/dL
SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)

Renal:

Creatinine no greater than 2.0 mg/dL
Calculated creatinine clearance at least 60 mL/min

Cardiovascular:

No uncontrolled angina, heart failure, or arrhythmia
No acute changes on EKG

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
HIV negative
No AIDS
Adequate nutritional status (total protein at least 60.0 g/L)
No active bacterial infections (e.g., abscess or with fistula)
No nonmalignant disease that would preclude study
No history of alcoholism, drug addiction, or psychotic disorders that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Prior bone marrow transplantation allowed
At least 4 weeks since prior immunotherapy or cytokines

Chemotherapy:

See Disease Characteristics
Prior intensive chemotherapy with stem cell support allowed
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high dose carboplatin)

Endocrine therapy:

No concurrent corticosteroids

Radiotherapy:

At least 4 weeks since prior radiotherapy to more than 25% of bone marrow

Surgery:

Recovered from prior surgery
No prior solid organ transplantation

Other:

No concurrent antiinflammatory agents including aspirin, or over the counter or prescription nonsteroidal antiinflammatory drugs
No concurrent immunosuppressive agents
No other concurrent investigational agents