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Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma Clinical research trials and Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma. Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 > "M" Clinical Trials Conditions > Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma  Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma
Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma
For Condition: recurrent grade 3 follicular lymphoma,recurrent grade 1 follicular lymphoma,recurrent grade 2 follicular lymphoma
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one monoclonal antibody may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining two different monoclonal antibodies in treating patients who have relapsed or refractoryfollicular non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the safety profile and recommended phase II dose of IDEC-114 monoclonal antibody and rituximab in patients with relapsed or refractory follicular non-Hodgkin's lymphoma. - Determine the pharmacokinetics of this regimen in these patients. - Determine the efficacy of this regimen in these patients. - Determine the immunogenicity of this regimen in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study of IDEC-114 monoclonal antibody (IDEC-114). - Patients receive IDEC-114 IV over 1 hour on days 3, 8, 15, and 22 and rituximab IV on days 1, 8, 15, and 22. Cohorts of 3-6 patients receive escalating doses of IDEC-114 until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive IDEC-114 at the MTD and rituximab as in phase I. Patients are followed at days 29, 36, 43, and 50; months 3 and 6; every 3 months for 1.5 years; and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 39-48 patients (9-18 patients for phase I and 30 patients for phase II) 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 follicular non-Hodgkin's lymphoma (NHL) - Relapsed after or refractory to primary therapy - Progressive disease after at least 1 prior standard therapy, including chemotherapy, radiotherapy, biologic therapy, or bone marrow or stem cell transplantation - Bidimensionally measurable disease - At least one lesion at least 2.0 cm - No disease refractory to prior rituximab - No pleural or peritoneal effusion with positive cytology for lymphoma - No prior aggressive NHL or mantle cell lymphoma - No chronic lymphocytic leukemia - No CNS lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - Hemoglobin at least 8.0 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL - AST and/or ALT no greater than 2 times upper limit of normal Renal - Creatinine no greater than 2.0 mg/dL - No hydronephrosis Cardiovascular - No congestive heart failure - No New York Heart Association class III or IV heart disease - No myocardial infarction within the past 6 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 12 months after study participation - HIV negative - No other primary malignancy requiring active treatment (except hormonal therapy) - No active uncontrolled bacterial, viral, or fungal infection - No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - More than 3 weeks since prior biologic therapy for cancer - More than 6 months since prior antibody therapy for lymphoma - More than 6 months since prior bone marrow or stem cell transplantation - No prior IDEC-114 or other anti-CD80 antibody Chemotherapy - See Disease Characteristics - More than 3 weeks since prior chemotherapy for cancer (6 weeks for nitrosoureas or mitomycin) Endocrine therapy - More than 3 weeks since prior prednisone Radiotherapy - See Disease Characteristics - More than 3 weeks since prior radiotherapy for cancer - More than 6 months since prior radioimmunotherapy for lymphoma Surgery - More than 4 weeks since prior major surgery (except diagnostic surgery) Other - Recovered from prior therapy - More than 3 weeks since other prior immunosuppressive therapy - Prior investigational drugs allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristosEmmanouilides, Principal Investigator, Jonsson Comprehensive Cancer Center
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Julie Vose 402-559-3848
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Christos Emmanouilides 310-206-0716
Additional Information:
Study ID Numbers: CDR0000271926; IDEC-114-21,UNMC-04703,UCLA-0207122
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056043
Other Recurrent Grade 3 Follicular Lymphoma Studies:
1. Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse
2. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Older Patients With Refractory or Relapsed Intermediate-Grade Non-Hodgkin's Lymphoma
3. Bortezomib With or Without Combination Chemotherapy in Treating Patients With Relapsed or Refractory Lymphoma
4. Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
5. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade 3 follicular lymphoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma
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