|
Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab Clinical research trials and Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab. Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab clinical trial. Participants frequently obtain the most expert healthcare available for their Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab  Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab
Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab
For Condition: recurrent grade 1 follicular lymphoma,recurrent grade 3 follicular lymphoma,recurrent grade 2 follicular lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma
Status: Recruiting
Sponsor(s): Jonsson Comprehensive 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. Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells. It is not yet known whether combining rituximab with interleukin-2 is effective in treating low-grade or follicular non-Hodgkin's lymphoma that has not responded to rituximab alone. PURPOSE: Phase II/III trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have low-grade or follicular non-Hodgkin's lymphoma that is refractory to rituximab.
Details: OBJECTIVES: - Determine the complete and partial response rate in patients with low-grade or follicular non-Hodgkin's lymphoma refractory to prior single-agent rituximab when treated with rituximab and interleukin-2. - Determine the safety of this regimen in these patients. - Determine the time to progression in patients treated with this regimen. - Determine the pharmacokinetics of interleukin-2 in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9 in the absence of unacceptable toxicity. Patients are followed every 4 weeks for approximately 1.5 years or until disease progression. PROJECTED ACCRUAL: A total of 12-150 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 B-cell non-Hodgkin's lymphoma - Low-grade or follicular - CD20+ disease - Measurable disease - Relapsed or unresponsive disease after a single-agent course of rituximab - Relapsed less than 6 months after therapy - Prior rituximab dose at least 75% of the total standard labeled dose (standard dose is 4 weekly doses at 375 mg/m^2) - No prior rituximab in combination with chemotherapy or another therapeutic modality (e.g., radiotherapy or radioimmunoconjugates) - No mantle cell lymphoma or chronic lymphocytic leukemia - No primary CNS lymphoma or lymphomatous meningitis NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Lymphocyte count less than 20,000/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Bilirubin no greater than 3 mg/dL - Transaminases no greater than 2.5 times upper limit of normal - Hepatitis B surface antigen negative - No clinically significant hepatic dysfunction Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - No clinically significant cardiac dysfunction - No history of congestive heart failure unless stable for at least 6 months and currently asymptomatic - No history of myocardial infraction unless stable for at least 6 months and currently asymptomatic Pulmonary - No clinically significant pulmonary dysfunction Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - Able and willing to administer interleukin-2 in an outpatient setting or have an available personal assistant to do so - No history of autoimmune disease - No symptomatic thyroid disease requiring medical intervention - No serious, uncontrolled, active infection - No type I hypersensitivity or anaphylactic reactions to murine proteins, prior rituximab, or radioconjugated CD20 antibody - No other prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated solid tumor and without evidence of recurrence for at least 1 year PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior allogeneic bone marrow transplantation - Prior autologous peripheral blood stem cell transplantation allowed - No prior interleukin-2 - No concurrent interferon alfa, interferon beta, or interferon gamma - No concurrent monoclonal antibody OKT3 Chemotherapy - See Disease Characteristics - More than 30 days since prior chemotherapy - No concurrent anticancer chemotherapy Endocrine therapy - Concurrent replacement treatment for hypothyroidism allowed - No concurrent systemic corticosteroids Radiotherapy - See Disease Characteristics - More than 30 days since prior radiotherapy - No concurrent radiotherapy Surgery - More than 30 days since prior major surgery Other - More than 6 weeks since prior experimental drugs - No concurrent mycophenolate mofetil, cyclosporine, or tacrolimus
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristosEmmanouilides, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Christos Emmanouilides 310-206-0716
Additional Information:
Study ID Numbers: CDR0000316263; UCLA-0302013,CHIR-IL2NHL03-A01
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066534
Other Recurrent Grade 3 Follicular Lymphoma Studies:
1. Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
2. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's 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. Radiolabeled Monoclonal Antibody in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
5. Combination Chemotherapy and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade 3 follicular lymphoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab
|
|
|
|
|
|
|
|
