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Clinical Trial: Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| recurrent diffuse small lymphocytic/marginal zone lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade III follicular large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma recurrent adult diffuse mixed cell lymphoma recurrent mantle cell lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia recurrent adult diffuse large cell lymphoma Waldenstrom's Macroglobulinemia recurrent grade I follicular small cleaved cell lymphoma B-cell Chronic Lymphocytic Leukemia recurrent grade II follicular mixed cell lymphoma | Drug: cisplatin Drug: cytarabine Drug: etoposide Drug: filgrastim Drug: ifosfamide Drug: indium In 111 LL2 IgG Drug: yttrium Y 90 humanized monoclonal antibody LL2 | Phase I |
MedlinePlus related topics: Blood and Blood Disorders; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphatic Diseases; Lymphoma; Vascular Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Yttrium Y 90 Humanized Anti-CD22 LL2 in Combination With Salvage Chemotherapy and Autologous Peripheral Blood Stem Cell Rescue in Patients With Recurrent or Refractory B-Cell Malignancies
Study start: June 1997
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
Ages Eligible for Study: 18 Years and above
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
Location Information
Jack D. Burton, Study Chair, Garden State Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: April 2004
Last Updated: October 13, 2004
Record first received: December 10, 1999
ClinicalTrials.gov Identifier: NCT00004086
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Acute Lymphoblastic Leukemia, Adult (National Cancer Institute)
- Hairy Cell Leukemia (Cleveland Clinic)

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