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Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00060164
  Purpose

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining rituximab with autologous vaccine therapy and sargramostim may cause a stronger immune response and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with autologous vaccine therapy and sargramostim in treating patients who have recurrent or refractory follicular B-cell lymphoma.


Condition Intervention Phase
Lymphoma
Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine
Drug: rituximab
Drug: sargramostim
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Rituximab    Sargramostim    Granulocyte-macrophage colony-stimulating factor    Immunoglobulins    Globulin, Immune   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase II Trial of Rituxan Plus FavId (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma

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

Study Start Date:   January 2003

Detailed Description:

OBJECTIVES:

  • Compare the 9-month objective response rate of patients with recurrent or refractory grade I or II follicular B-cell lymphoma treated with rituximab, autologous immunoglobulin idiotype-KLH conjugate vaccine, and sargramostim (GM-CSF) vs historical control patients who received rituximab alone.
  • Compare the median duration of response and median time to progression in patients treated with this regimen vs historical controls.
  • Determine the immune response (humoral and/or cellular) of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive rituximab IV once weekly for 4 weeks. Beginning at least 8 weeks later, patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine (Id-KLH) and sargramostim (GM-CSF) subcutaneously once monthly for a total of 6 months in the absence of disease progression or unacceptable toxicity.

Patients who achieve an objective response (complete response or partial response) or stable disease may continue to receive Id-KLH and GM-CSF every other month for a total of 6 doses and then every 3 months in the absence of disease progression.

Patients are followed every 6 months for at least 2 years.

PROJECTED ACCRUAL: A total of 44 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 grade I or II follicular B-cell lymphoma
  • Must meet one of the following criteria for relapsed/refractory disease:

    • Relapsed or refractory after prior chemotherapy
    • Relapsed after prior rituximab

      • Rituximab may have been given as second-line therapy after an initial response to chemotherapy or in combination with chemotherapy as initial therapy
  • No more than 2 prior treatment regimens

    • Cyclophosphamide/doxorubicin/prednisone/vincristine (CHOP) and rituximab is considered 1 prior treatment regimen
    • CHOP followed by rituximab at initial relapse is considered 2 prior treatment regimens
  • Measurable disease after node biopsy

    • At least 1 bidimensionally measurable lesion
    • If only 1 measurable lesion remains after biopsy, it must be at least 2 cm in each dimension
  • Tumor accessible for biopsy or prior recent biopsy material available
  • No known history of CNS lymphoma or meningeal lymphomatosis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,000/mm^3
  • Lymphocyte count less than 5,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • AST and ALT no greater than 2 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • No congestive heart failure

Pulmonary

  • No compromised pulmonary function that would preclude study participation, including any of the following:

    • Active asthma
    • Chronic obstructive pulmonary disorder
    • Pneumonitis
    • Bronchiolitis obliterans

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No active uncontrolled bacterial, viral, or fungal infection
  • No other concurrent nonmalignant disease that would preclude study participation
  • No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior tumor-specific idiotype immunotherapy using the identical idiotype

Chemotherapy

  • See Disease Characteristics
  • More than 9 months since prior fludarabine

Endocrine therapy

  • No concurrent high-dose steroid therapy

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational drugs
  • No concurrent immunosuppressive therapy
  • No other concurrent anticancer therapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060164

Locations
United States, Ohio
Ireland Cancer Center    
      Cleveland, Ohio, United States, 44106

Sponsors and Collaborators
Ireland Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Omer N. Koc, MD     Case Comprehensive Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000299533, CWRU-FVID-1402, FAV-ID-04
First Received:   May 6, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00060164
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  

Study placed in the following topic categories:
Immunoproliferative Disorders
Immunoglobulin Idiotypes
Rituximab
Lymphoma, Follicular
Recurrence
Lymphoma, B-Cell
Lymphatic Diseases
B-cell lymphomas
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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