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Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia  Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia
For Condition: Leukemia,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. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have lymphoma or leukemia that has not responded to previous chemotherapy.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of yttrium Y 90-labeled humanized anti-CD22 monoclonal antibody LL2(90Y-hLL2 IgG) in patients with B-cell malignancies. II. Determine the pharmacokinetics and biodistribution of indium In 111 humanized LL2 (111In-hLL2 IgG) in these patients. III. Evaluate the immunogenicity of repeated injections of 90Y-hLL2 IgG in these patients. IV. Determine whether 90Y-hLL2 IgG versus indium In 131 humanized LL2 IgG has a therapeutic advantage based on organ and tumor dosimetry obtained with 111In-hLL2 IgG. PROTOCOL OUTLINE: This is a dose escalation study. Patients are stratified into risk groups (high vs low). Patients receive pretherapy imaging with indium In 111 humanized LL2 IgG IV for up to 30 minutes on days -7 to 0. Patients receive yttrium Y 90-labeled humanized anti-CD22 monoclonal antibody LL2 (90Y-hLL2-IgG) IV for up to 30 minutes on day 0. Cohorts of 3-6 patients receive escalating doses of 90Y-hLL2-IgG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding the dose at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed every 2 weeks for 1 month, monthly for 2 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1-2 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 B-cell malignancy, including B-cell non-Hodgkin's lymphoma or B-cell chronic lymphocytic leukemia, that has failed at least one regimen of standard chemotherapy - At least 1 confirmed tumor site by radiolabeled LL2 IgG - No greater than 25% bone or bone marrow involvement - No brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Prior murine monoclonal antibody therapy allowed (if unreactive to yttrium Y 90-labeled humanized anti-CD22 monoclonal antibody LL2 by HPLC or ELISA test) - Chemotherapy: At least 4 weeks since prior chemotherapy - Endocrine therapy: At least 2 weeks since prior corticosteroids (except for adrenal insufficiency) - Radiotherapy: At least 4 weeks since prior radiotherapy to the index lesion; No prior extensive radiotherapy to greater than 25% of bone marrow (except total body irradiation as part of bone marrow or stem cell transplantation regimen with engraftment of functional marrow (i.e., producing normal peripheral blood counts); No prior maximum tolerated dose levels of radiotherapy to critical organs (e.g., lung, liver, or kidney) - Surgery: At least 4 weeks since prior major surgery - Other: No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - 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 mg/dL; AST and alkaline phosphatase less than 1.5 times upper limit of normal (ULN) (except for bone involvement) - Renal: Creatinine less than 1.5 times ULN - Other: Not pregnant; Fertile patients must use effective contraception during and for 3-6 months after study; HIV negative; No severe anorexia, nausea, or vomiting; No other significant concurrent medical condition that would interfere with compliance
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
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: CDR0000067295; CMMI-C-037A-97,NCI-H99-0041,NCI-V99-1567
Study Start Date: April 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004084
Other Lymphoma Studies:
1. VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
2. Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
3. Phase I Study of Carbendazim in Patients With Advanced Solid Tumors or Lymphoma
4. PS-341 in Treating Patients With Advanced Cancer
5. Anti-Human CD45 Monoclonal Antibodies in Patients with Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation
Related Studies:
Other Lymphoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia
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