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Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma Clinical research trials and Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma. Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma clinical trial. Human subjects often get the best healthcare possible for their Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma  Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma
Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma
For Condition: recurrent adult diffuse large cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ireland Cancer Center
Synopsis: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in treating patients who have large cell lymphoma that has been previously treated.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody Lym-1 in patients with previously treated diffuse large cell lymphoma. II. Determine the safety of this drug in these patients. III. Determine the response of patients to this drug. PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients receive unlabeled monoclonal antibody Lym-1 IV over 40 minutes followed 15-30 minutes later by iodine I 131 monoclonal antibody Lym-1 IV over 2 minutes. Cohorts of 3-6 patients receive escalating doses of iodine I 131 monoclonal antibody Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 8 weeks and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 8-36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed B-cell diffuse large cell lymphoma - L-26 positive (i.e., CD20-positive) Failed 2 prior chemotherapy regimens At least 1 measurable lesion - At least 2 cm by physical exam or CT scan No active lymphomatous meningitis or other CNS involvement by lymphoma No significant marrow involvement (i.e., more than 20% of hematopoietic marrow elements from iliac crest biopsy) --Prior/Concurrent Therapy-- Biologic therapy: - No prior bone marrow or peripheral blood stem cell transplantation - No prior radioimmunotherapy - Prior unlabeled monoclonal antibody therapy allowed - At least 120 hours since prior filgrastim (G-CSF) or sargramostim (GM-CSF) - At least 1 month since prior epoetin alfa Chemotherapy: - See Disease Characteristics - No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: - See Biologic therapy - No prior total body irradiation (TBI) - At least 6 months since prior radiotherapy (over 3,00 cGy) to more than 20% of marrow-bearing space (i.e., pelvis and spine) - No concurrent large-field radiotherapy (i.e., TBI, hemibody radiation, or radiation fields that include more than 20% of active marrow to a dose of over 3,000 cGy) - Concurrent localized radiotherapy is allowed to current or impending serious complication (e.g., bronchial obstruction by hilar lymph nodes or impending fracture due to lytic bone lesions) Surgery: Not specified Other: - Recovered from prior anti-lymphoma therapy - At least 120 hours since prior whole blood or platelet transfusion - No concurrent anticoagulants or antiplatelet drugs - No concurrent medications known to inhibit blood clotting or platelet aggregation (e.g., aspirin) --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: - WBC at least 3,500/mm3 - Granulocyte count at least 1,500/mm3 - Platelet count at least 125,000/mm3 Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST/ALT no greater than 3 times ULN - Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2 times ULN Cardiovascular: - No electrocardial evidence of Q-wave myocardial infarction within the past 6 months - No congestive heart failure - No New York Heart Association class III or IV heart disease Other: - HIV negative - Negative human anti-mouse antibodies (i.e., less than 74 ng/mL) - No known antiplatelet antibodies - No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OmerKoc, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Additional Information:
Study ID Numbers: CDR0000069110; BRLX-303680,CWRU-090036,NCI-G01-2038,CWRU-BRLX-1400
Study Start Date: March 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028613
Other Recurrent Adult Diffuse Large Cell Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
2. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
3. LY317615 in Treating Patients With Relapsed or Refractory Lymphoma
4. BMS-247550 in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
5. Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent adult diffuse large cell lymphoma Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma
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