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.
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
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 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
- More than 30 days since prior investigational drugs
- No concurrent immunosuppressive therapy
- No other concurrent anticancer therapy
Location Information
Omer N. Koc, MD, Study Chair, Ireland Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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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