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


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Sargramostim Injection

GM-CSF; Leukine; Prokine



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

This study is no longer recruiting patients.

Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 refractoryfollicular B-cell lymphoma.

Condition Treatment or Intervention Phase
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
 Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine
 Drug: rituximab
 Drug: sargramostim
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: monoclonal antibody therapy
 Procedure: tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Rituximab, Autologous Immunoglobulin Idiotype-KLH Conjugate Vaccine, and Sargramostim (GM-CSF) in Patients With Recurrent or Refractory Grade I or II Follicular B-Cell Lymphoma

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

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


Location Information


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

Study chairs or principal investigators

Omer N. Koc, MD,  Study Chair,  Ireland Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000299533; CWRU-FVID-1402; FAV-ID-04
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00060164
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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