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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.
Study NCT00060164   Information provided by National Cancer Institute (NCI)
First Received: May 6, 2003   Last Updated: February 6, 2009   History of Changes

May 6, 2003
February 6, 2009
January 2003
 
 
 
Complete list of historical versions of study NCT00060164 on ClinicalTrials.gov Archive Site
 
 
 
Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma
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

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.

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.

Phase II
Interventional
Treatment, Open Label
Lymphoma
  • Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine
  • Biological: rituximab
  • Biological: sargramostim
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00060164
 
CDR0000299533, CWRU-FVID-1402, FAV-ID-04
Ireland Cancer Center
National Cancer Institute (NCI)
Study Chair: Omer N. Koc, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP