Rituximab Plus Beta-Glucan in Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)

This study has been terminated.
(terminated due to lack of accrual)
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00290407
First received: February 9, 2006
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine how well subjects respond to treatment with Rituximab plus Beta-Glucan.


Condition Intervention Phase
Leukemia, Lymphocytic, Chronic
Lymphoma, Small Lymphocytic
Drug: Rituximab
Dietary Supplement: Beta-Glucan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Rituximab Plus B-Glucan in Patients With Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • CT Scan to Measure Clinical Effect (Response) [ Time Frame: 3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression ] [ Designated as safety issue: No ]
    Study terminated, results data not available


Secondary Outcome Measures:
  • Blood Specimens Will be Collected to Measure Immunologic Effect [ Time Frame: at weeks 4, 8, 12, and at month 6 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: March 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    375 mg/m2, IV (in the vein), once a week for 4 weeks
    Other Name: Rituxan
    Dietary Supplement: Beta-Glucan
    250 mg, orally (tablet), three times a day for 9 weeks
    Other Name: Imucell WGP
Detailed Description:

Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults. CLL is a cancer of the B-lymphocytes, which make antibodies that help protect the body against harmful foreign substances, such as bacteria and viruses. Similar to CLL, small lymphocytic lymphoma (SLL) is a less-common cancer of the B-lymphocytes. In SLL, the abnormal lymphocytes mainly affect the lymph nodes; in CLL, the abnormal lymphocytes mainly affect the blood and bone marrow.

Current drug therapies for CLL/SLL are known to increase the severity of pre-existing low blood cell counts, which in turn increase the risk of infections in patients. Research to improve the safety and effectiveness of CLL/SLL therapy is currently ongoing. One such therapy being investigated is Rituximab.

Rituximab is a type of drug known as a therapeutic antibody. Therapeutic antibodies are laboratory-created substances that attach onto a protein on the surface of a cell. After binding to the cell, the therapeutic antibody can block the growth of the tumor and/or trigger the body's immune system to attack the target, and can also sensitize a cancer cell to chemotherapy. Rituximab is approved by the Food and Drug Administration (FDA) for the treatment of CLL/SLL.

Beta-Glucan (Imucell WGP) is an over-the-counter dietary supplement that enhances the body's immune system. ImucellTM WGP is extracted from food-grade baker's yeast, which is permitted for use in food by the FDA. Animal studies have shown that Imucell WGP helps trigger the white blood cells to destroy cancer cells. Other animal studies combining Rituximab with Imucell WGP have shown greater tumor regression and tumor-free survival.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • definitive diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
  • Patients with CLL must have active, progressive, or symptomatic Rai stage II, III, or IV disease. Patients with SLL must have active, progressive or symptomatic stages II, III, IV disease by the Ann Arbor Staging system. Patients with stage I CLL are eligible only if they have systemic symptoms requiring treatment.
  • Patients may be treatment naïve, refractory to primary therapy, or relapsed not more than four times) and have measurable or assessable disease. Bone marrow involvement alone will not be acceptable as measurable disease in case of lymphoma.
  • Prior therapies may include chemotherapy, radiation, autologous stem cell transplant, or Rituximab.
  • Patients who have received therapy must be at least 4 weeks beyond prior standard chemotherapy including corticosteroids, 3 months beyond radiation therapy, and have recovered from significant toxicities from prior therapies
  • age > 18 years
  • life expectancy of greater than 12 weeks
  • ECOG performance status 0, 1, or 2 (Karnofsky > 50%)
  • adequate bone marrow function, as defined by: absolute neutrophil count > 1000/µl; platelets > 20,000/µl
  • adequate liver function, as defined by: total bilirubin < 2, albumin > 2.5 g/dl, and no ascites; AST(SGOT), ALT(SGPT) & Alkaline Phosphatase < 2.5 x upper limit of normal
  • adequate renal function, as defined by: creatinine < 2.5 mg/dl or a creatinine clearance > 30 mL/min (measured or estimated by the Cockcroft-Gault formula) for patients with creatinine levels above 2.5 mg/dl
  • must have recovered from acute toxicities resulting from prior therapy to less than grade 1. Alopecia may not be resolved.
  • ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

  • patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry or who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • severe autoimmune hemolytic anemia; CNS involvement (either parenchymal or meningeal); severe lymphoma-related symptoms requiring a rapid response to therapy (eg, respiratory compromise due to large effusions or airway obstruction, bowel obstruction, ureteral obstruction, and chylous ascites)
  • patients receiving any other investigational agent(s)
  • active second malignancy in the last 5 years, except for non-melanoma skin cancer or carcinoma-in-situ
  • history of hypersensitivity reactions attributed to Beta-Glucan
  • history of connective tissue or autoimmune disease
  • patients receiving corticosteroids for any reason, except as a part of treatment for autoimmune hemolytic anemia or immune thrombocytopenia
  • uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290407

Locations
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Roger H Herzig, MD James Graham Brown Cancer Center/University of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00290407     History of Changes
Other Study ID Numbers: 008.06, BCC-HEM-06-001
Study First Received: February 9, 2006
Results First Received: May 3, 2013
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by James Graham Brown Cancer Center:
chronic lymphocytic leukemia
small lymphocytic lymphoma
rituximab
beta-glucan

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 15, 2014