Expired Study
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Cleveland, Ohio 44106


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.


Study summary:

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.


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


NCT ID:

NCT00060164


Primary Contact:

Study Chair
Omer N. Koc, MD
Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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