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Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immu-LL2: Treatment With 90Y-hLL2 IgG


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immu-LL2: Treatment With 90Y-hLL2 IgG


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.

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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Jack D. Burton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Garden State Cancer Center at the Center for Molecular Medicine and Immunology

Authority:

United States: Federal Government

Study ID:

CDR0000067295

NCT ID:

NCT00004084

Start Date:

April 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult Burkitt lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Garden State Cancer CenterBelleville, New Jersey  07103