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Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma Clinical research trials and Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma. Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma  Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma
Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma
For Condition: recurrent grade 1 follicular lymphoma,recurrent grade 2 follicular lymphoma
Status: No longer recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OmerKoc, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: CDR0000299533; CWRU-FVID-1402,FAV-ID-04
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060164
Other Recurrent Grade 2 Follicular Lymphoma Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy
2. Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma
3. FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma
4. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
5. Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade 2 follicular lymphoma Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma
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