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Beta Alethine in Treating Patients With Low-Grade Lymphoma
This study is ongoing, but not recruiting participants.
Sponsored by: LifeTime Pharmaceuticals
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00007839
  Purpose

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 Intervention Phase
Lymphoma
Drug: beta alethine
Phase I
Phase II

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2000
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007839

Locations
United States, Maryland
Victory Over Cancer
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
LifeTime Pharmaceuticals
Investigators
Study Chair: Suzin Mayerson, PhD LifeTime Pharmaceuticals
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000068279, LIFETIME-LTP-99-02, LIFETIME-IRB-0300202, NCI-V00-1628
Study First Received: January 6, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00007839  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Recurrence
Lymphoma, B-Cell
Lymphatic Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009