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.

Sponsored by: Garden State Cancer Center
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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--

--Prior/Concurrent Therapy--

--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


New Jersey
      Garden State Cancer Center, Belleville,  New Jersey,  07103,  United States

Study chairs or principal investigators

Jack D. Burton,  Study Chair,  Garden State Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067298; CMMI-C-037C-97; NCI-V99-1569
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