|
Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia 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 Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia Clinical research trials and Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia 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 Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia 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 Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia clinical trial. Test subjects typically receive the most effective healthcare possible for their Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia 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.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia  Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
For Condition: B-cell adult acute lymphoblastic leukemia,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent mantle cell lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,Waldenstrom's Macroglobulinemia,B-cell Chronic Lymphocytic Leukemia,recurrent adult acute lymphoblastic leukemia,recurrent adult diffuse small cleaved cell lymphoma,recurrent grade II follicular mixed cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent adult diffuse large cell lymphoma,recurrent adult diffuse mixed cell lymphoma,refractory chronic lymphocytic leukemia,recurrent adult lymphoblastic lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Garden State Cancer Center
Synopsis: RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus peripheral stem cell transplantation in treating patients who have lymphoma or Waldenstrom's macroglobulinemia that has not responded to previous therapy.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of radioimmunotherapy using high dose yttrium Y 90 humanized anti-CD22 monoclonal antibody LL2 (Y90 MOAB hLL2) followed by autologous peripheral blood stem cell transplantation in patients with B cell lymphomas or Waldenstrom's macroglobulinemia. II. Determine the organ and tumor dosimetry for comparison to clinical measurement of toxicity and antitumor responses in these patients. III. Determine magnitude and duration of human anti-humanized LL2 antibody (HAhLL2) or anti-DOTA response in these patients. IV. Evaluate the extent and duration of antitumor response to this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to prior treatment (high dose chemotherapy with transplantation vs low dose chemotherapy with radioimmunotherapy (RAIT) vs low dose chemotherapy without RAIT). Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 5 days and undergo harvest of peripheral blood stem cells (PBSC). If an adequate number of CD34+ cells are not harvested, autologous bone marrow may be used. Patients undergo pretherapy imaging with indium In 111 monoclonal antibody MN-14 (In111-MN-14) IV on day -7. If at least 1 tumor site is targeted, patients receive high dose yttrium Y 90 humanized anti-CD22 monoclonal antibody LL2 (Y90 MOAB hLL2) IV for up to 50 minutes on day 0. PBSC or bone marrow is reinfused approximately 7-14 days following infusion of Y90 MOAB hLL2. Patients also receive G-CSF SC daily until 3 days after blood counts have recovered. 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 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: A total of 12-24 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven B cell lymphoma of one of the following types: Any histologic grade of non-Hodgkin's lymphoma; Chronic lymphocytic leukemia; CD22 positive acute lymphocytic leukemia; Waldenstrom's macroglobulinemia - Must have failed at least 1 standard therapy - Autologous peripheral blood stem cells (PBSC) or bone marrow available - Bone marrow involvement allowed if: Autologous bone marrow or PBSC with no greater than 5% tumor involvement available; Radiation dose to marrow no greater than 3,000 cGy until 6 patients have been safely treated at that dose level - At least 1 confirmed site of tumor targeted by pretherapy indium; In 111 monoclonal antibody MN-14 imaging - No brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior radioimmunotherapy AND high dose chemotherapy - Chemotherapy: No prior high dose chemotherapy AND radioimmunotherapy; At least 4 weeks since other prior chemotherapy and recovered - Endocrine therapy: At least 2 weeks since prior corticosteroids and recovered Radiotherapy: No prior radioimmunotherapy AND high dose chemotherapy; At least 4 weeks since prior radiotherapy to index lesion; No prior radiotherapy to greater than 25% of any critical organ (e.g., lung, liver, kidneys); No prior total body irradiation - Surgery: At least 4 weeks since prior major surgery --Patient Characteristics-- - Age: 18 to 80 - Performance status: Karnofsky 70-100%; ECOG 0-2 - 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 no greater than 2.0 mg/dL; AST and alkaline phosphatase less than 1.5 times upper limit of normal (ULN) in the absence of bone involvement - Renal: Creatinine less than 1.5 times ULN - Cardiovascular: Ejection fraction at least 50% - Pulmonary: DLCO at least 60% of predicted; Forced vital capacity at least 60% of predicted - Other: No severe anorexia, nausea, or vomiting; No concurrent significant medical complications that would preclude study participation; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study; HIV negative
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
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: CDR0000067327; CMMI-C-037B-97,NCI-H99-0040,UPCC-1499
Study Start Date: February 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004107
Other Recurrent Adult Lymphoblastic Lymphoma Studies:
1. Radiation Therapy and Cyclophosphamide Plus Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma
2. Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
3. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
4. Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
5. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
Related Studies:
Other recurrent adult lymphoblastic lymphoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
|
|
|
|
|
|
|
|
