|
Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer Clinical research trials and Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer  Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
For Condition: recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent adult diffuse large cell lymphoma,recurrent adult lymphoblastic lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,recurrent mantle cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent grade III follicular large cell lymphoma,refractory hairy cell leukemia,refractory chronic lymphocytic leukemia,Waldenstrom's Macroglobulinemia,recurrent adult diffuse small cleaved cell lymphoma,recurrent adult immunoblastic large cell lymphoma,B-cell Chronic Lymphocytic Leukemia,recurrent grade II follicular mixed cell lymphoma
Status: No longer recruiting
Sponsor(s): Garden State Cancer Center ,
Synopsis: RATIONALE: Radiolabeled 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 I trial to study the effectiveness of radiolabeled monoclonal antibody plus combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or B-cell cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of yttrium Y 90 humanized anti-CD22 LL2 (Y90 MOAB hLL2) in combination with salvage chemotherapy and autologous peripheral blood stem cell rescue in patients with recurrent or refractory B-cell malignancies. II. Study the effect of chemotherapy on the uptake of Y90 MOAB hLL2 into tumor sites and normal organs by pretherapy imaging using indium In 111 humanized LL2 and intratherapy imaging. III. Determine the extent and duration of tumor response in patients receiving this regimen. PROTOCOL OUTLINE: This is a dose escalation study of yttrium Y 90 humanized anti-CD22 monoclonal antibody LL2 (Y90 MOAB hLL2). Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days and undergo harvest of peripheral blood stem cells (PBSC) on 2 or more consecutive days. If an adequate number of CD34+ cells are not harvested, autologous bone marrow may be used. Chemotherapy-induced mobilization with filgrastim allowed. Patients undergo pretherapy imaging with indium In 111 humanized LL2 (In111 hLL2) for up to 40 minutes on day -7. Patients receive Y90 MOAB hLL2 for up to 40 minutes on day 0 plus In111 hLL2, followed by Y90 MOAB hLL2 alone on day 3. Patients receive ifosfamide IV over 1 hour, cisplatin IV over 2 hours, and cytarabine IV over 2 hours on days 1 and 4. Oral etoposide is given daily on days 1-7. PBSC or bone marrow is reinfused on days 9-14, depending on MOAB clearance. Cohorts of 3-6 patients receive escalating doses of Y90 MOAB hLL2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed weekly for 2 months, monthly for 6 months, and then every 6 months for 5 years. PROJECTED ACCRUAL: Approximately 15-24 patients will be accrued for this study within 2-2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed recurrent or refractory B-cell malignancy that has failed at least one standard therapy; Stage II to IV non-Hodgkin's lymphoma B-cell chronic lymphocytic leukemia, hairy cell leukemia, or Waldenstrom's macroglobulinemia allowed if: Autologous bone marrow or peripheral blood stem cells (PBSC) with no greater than 5% tumor involvement available; Estimated radiation dose to marrow no greater than 3,000 cGy (bone marrow involvement of greater than 25% is allowed provided stem cell contamination and predicted marrow radiation doses are below the above cited cut off values) - At least 1 confirmed site of tumor targeted by pretherapy indium In 111 humanized LL2 - Autologous peripheral blood stem cells (PBSC) or bone marrow available - No active brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Prior low dose radioimmunotherapy allowed - Chemotherapy: No prior high dose chemotherapy with PBSC rescue; At least 4 weeks since prior chemotherapy and recovered - Endocrine therapy: At least 2 weeks since prior corticosteroids and recovered - Radiotherapy: Prior low dose radioimmunotherapy allowed; Prior radiotherapy to less than 35% of red marrow allowed; At least 4 weeks since prior radiotherapy to index lesion - Surgery: At least 4 weeks since major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2; Karnofsky 70-100% - Life expectancy: At least 3 months - Hematopoietic: WBC at least 3,000/mm3; Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 2 mg/dL - Renal: Creatinine less than 1.5 times upper limit of normal - Cardiovascular: Cardiac ejection fraction greater than 50% - Pulmonary: DLCO greater than 60% predicted; Forced vital capacity greater than 60% predicted - Other: No severe anorexia, nausea, or vomiting; HIV negative; No prisoners; No concurrent significant medical complication that would preclude study compliance; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JackBurton, Study Chair, Garden State Cancer Center
Garden State Cancer Center
Belleville, New Jersey, 07103
United States
Additional Information:
Study ID Numbers: CDR0000067298; CMMI-C-037C-97,NCI-V99-1569
Study Start Date: June 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004086
Other Refractory Hairy Cell Leukemia Studies:
1. Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia
2. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
3. Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia
4. Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
5. High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Related Studies:
Other refractory hairy cell leukemia Clinical Trials
Other New Jersey Clinical Trials
Other Belleville Clinical Trials
Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
|
|
|
|
|
|
|
|
