Clinical trial NCT00007839: Beta Alethine in Treating Patients With Low-Grade Lymphoma
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lymphoma
Keywords: stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-10-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Victory Over Cancer
state: Maryland
Study officials:
affiliation: LifeTime Pharmaceuticals
name: Suzin Mayerson, PhD
role: STUDY_CHAIR
References: