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Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Clinical research trials and Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma. Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma clinical trial. Subjects often receive the most expert healthcare possible for their Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma  Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
For Condition: recurrent adult immunoblastic large cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent adult diffuse large cell lymphoma
Status: Recruiting
Sponsor(s): University of Nebraska ,
Synopsis: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy, combination chemotherapy, and peripheral stem cell transplantation in treating patients who have relapsed or refractorynon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Compare the response rates and time to treatment failure in patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 monoclonal antibody anti-B1, followed by high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM), and autologous peripheral blood stem cell transplantation (APBSCT) vs historical control patients treated with high-dose BEAM or carmustine, etoposide, cytarabine, and cyclophosphamide and APBSCT. - Determine the safety of this regimen in these patients. OUTLINE: Autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells or granulocyte macrophage colony-forming units. On day -19, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV followed by a dosimetric dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. On day -12, patients receive unlabeled MOAB anti-B1 IV followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. Patients then receive high-dose chemotherapy comprising carmustine IV on day -6, etoposide IV and cytarabine IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous PBSC transplantation on day 0. Patients are followed at days 30 and 100, at 6 months, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of non-Hodgkin's lymphoma (NHL) of one of the following types: - Diffuse large B-cell - Composite (at least 50% of tumor showing diffuse histology) - Diffuse mixed cell - Immunoblastic - Relapsed or refractory disease sensitive to initial or subsequent conventional therapy (at least a partial response) - Eligible for high-dose carmustine, etoposide, cytarabine, and melphalan protocol and autologous bone marrow transplantation or peripheral blood stem cell transplantation - Evidence of CD20 antigen expression in tumor tissue - Bidimensionally measurable disease - No progressive disease in a field that has been previously irradiated with more than 3,500 cGy within the past year - Adequate peripheral blood stem cells - At least 15,000,000 CD34+ cells/kg OR - At least 25,000 granulocyte macrophage colony-forming units/kg - No known brain or leptomeningeal metastases PATIENT CHARACTERISTICS: Age: - 19 to 70 Performance status: - Karnofsky 70-100% Life expectancy: - At least 4 months posttransplantation Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin less than 2.0 mg/dL Renal: - Creatinine less than 2.0 mg/dL - No active obstructive hydronephrosis Cardiovascular: - Cardiac ejection fraction at least 40% for any of the following criteria: - Age 60 and over - Significant cardiac history (myocardial infarction or congestive heart failure) - Received greater than 350 mg/m^2 of prior doxorubicin - No New York Heart Association class III or IV heart disease Pulmonary: - DLCO at least 50% of predicted Other: - No evidence of severe organ dysfunction - No other major medical illnesses - No active infection requiring IV antibiotics - No other malignancy within the past 5 years except adequately treated skin cancer or carcinoma in situ of the cervix - HIV negative - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study participation - Human antimouse antibody negative - No vulnerability PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior peripheral blood stem cell transplantation following high-dose chemotherapy or chemoradiotherapy - At least 4 weeks since prior biologic therapy and recovered - No other concurrent biologic therapy for NHL Chemotherapy: - See Disease Characteristics - See Biologic therapy - At least 4 weeks since prior cytotoxic chemotherapy and recovered - No other concurrent chemotherapy or antineoplastic therapy for NHL Endocrine therapy: - No concurrent steroids except maintenance-dose steroids for noncancerous disease Radiotherapy: - See Disease Characteristics - See Biologic therapy - At least 4 weeks since prior radiotherapy and recovered - No concurrent external beam radiotherapy for NHL Surgery: - Not specified Other: - At least 4 weeks since prior immunosuppressants and recovered - No other concurrent participation on protocol involving non-FDA-approved drugs or biologics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulieVose, Study Chair, University of Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Julie Vose 402-559-3848
Additional Information:
Study ID Numbers: CDR0000068308; UNMC-051-00,COULTER-IND-3323
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006695
Other Recurrent Adult Immunoblastic Large Cell Lymphoma Studies:
1. Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Large Cell Lymphoma
2. Radiation Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Who Have Undergone Stem Cell Transplantation
3. Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy
4. BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
5. Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent adult immunoblastic large cell lymphoma Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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