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Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00006695   Information provided by National Cancer Institute (NCI)
First Received: December 6, 2000   Last Updated: February 6, 2009   History of Changes

December 6, 2000
February 6, 2009
April 2000
 
Maximum tolerated dose [ Designated as safety issue: Yes ]
Maximum tolerated dose
Complete list of historical versions of study NCT00006695 on ClinicalTrials.gov Archive Site
  • Clinical activity as assessed by tumor measurements using serial post-injection MRI scans, daily steroid use, and Karnofsky performance status evaluation [ Designated as safety issue: No ]
  • Time to tumor progression assessed by tumor measurements using MRI [ Designated as safety issue: No ]
  • Response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Clinical activity as assessed by tumor measurements using serial post-injection MRI scans, daily steroid use, and Karnofsky performance status evaluation
  • Time to tumor progression assessed by tumor measurements using MRI
  • Response
  • Overall survival
 
Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
BEAM Plus Iodine-131 Anti-B1 Antibody and Autologous Hematopoietic Stem Cell Transplantation for Treatment of Recurrent Diffuse Large B-Cell Non-Hodgkin's Lymphoma

RATIONALE: 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 transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well monoclonal antibody therapy, chemotherapy, and peripheral stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

OBJECTIVES:

  • Compare the response rates and time to treatment failure in patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 monoclonal antibody anti-B1, followed by high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM), and autologous peripheral blood stem cell transplantation (APBSCT) vs historical control patients treated with high-dose BEAM or carmustine, etoposide, cytarabine, and cyclophosphamide and APBSCT.
  • Determine the safety of this regimen in these patients.

OUTLINE: Autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells or granulocyte macrophage colony-forming units. On day -19, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV followed by a dosimetric dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. On day -12, patients receive unlabeled MOAB anti-B1 IV followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. Patients then receive high-dose chemotherapy comprising carmustine IV on day -6, etoposide IV and cytarabine IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous PBSC transplantation on day 0.

Patients are followed at days 30 and 100, at 6 months, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 years.

Phase II
Interventional
Treatment, Open Label
Lymphoma
  • Drug: carmustine
  • Drug: cytarabine
  • Drug: etoposide
  • Drug: melphalan
  • Procedure: bone marrow ablation with stem cell support
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: tositumomab and iodine I 131 tositumomab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
50
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of non-Hodgkin's lymphoma (NHL) of one of the following types:

    • Diffuse large B-cell
    • Composite (at least 50% of tumor showing diffuse histology)
    • Diffuse mixed cell
    • Immunoblastic
  • Relapsed or refractory disease sensitive to initial or subsequent conventional therapy (at least a partial response)
  • Eligible for high-dose carmustine, etoposide, cytarabine, and melphalan protocol and autologous bone marrow transplantation or peripheral blood stem cell transplantation
  • Evidence of CD20 antigen expression in tumor tissue
  • Bidimensionally measurable disease
  • No progressive disease in a field that has been previously irradiated with more than 3,500 cGy within the past year
  • Adequate peripheral blood stem cells

    • At least 15,000,000 CD34+ cells/kg OR
    • At least 25,000 granulocyte macrophage colony-forming units/kg
  • No known brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

  • 19 to 70

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 4 months posttransplantation

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin less than 2.0 mg/dL

Renal:

  • Creatinine less than 2.0 mg/dL
  • No active obstructive hydronephrosis

Cardiovascular:

  • Cardiac ejection fraction at least 40% for any of the following criteria:

    • Age 60 and over
    • Significant cardiac history (myocardial infarction or congestive heart failure)
    • Received greater than 350 mg/m^2 of prior doxorubicin
  • No New York Heart Association class III or IV heart disease

Pulmonary:

  • DLCO at least 50% of predicted

Other:

  • No evidence of severe organ dysfunction
  • No other major medical illnesses
  • No active infection requiring IV antibiotics
  • No other malignancy within the past 5 years except adequately treated skin cancer or carcinoma in situ of the cervix
  • HIV negative
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study participation
  • Human antimouse antibody negative
  • No vulnerability

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior peripheral blood stem cell transplantation following high-dose chemotherapy or chemoradiotherapy
  • At least 4 weeks since prior biologic therapy and recovered
  • No other concurrent biologic therapy for NHL

Chemotherapy:

  • See Disease Characteristics
  • See Biologic therapy
  • At least 4 weeks since prior cytotoxic chemotherapy and recovered
  • No other concurrent chemotherapy or antineoplastic therapy for NHL

Endocrine therapy:

  • No concurrent steroids except maintenance-dose steroids for noncancerous disease

Radiotherapy:

  • See Disease Characteristics
  • See Biologic therapy
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent external beam radiotherapy for NHL

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior immunosuppressants and recovered
  • No other concurrent participation on protocol involving non-FDA-approved drugs or biologics
Both
19 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006695
 
CDR0000068308, UNMC-051-00, COULTER-IND-3323
University of Nebraska
 
Study Chair: Julie M. Vose, MD University of Nebraska
National Cancer Institute (NCI)
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP