Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 19 to 70 Pharmaceutical / Industry UNMC-051-00 COULTER-IND-3323, NCT00006695

Objectives

1. 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.
2. Determine the safety of this regimen in these patients.

Entry Criteria

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

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

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/m² 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

Expected Enrollment

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

Outcomes

Maximum tolerated dose

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

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.

Trial Contact Information

Trial Lead Organizations

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Julie Vose, MD, Protocol chair		Ph: 402-559-3848 Email: jmvose@unmc.edu

Registry Information
Official Title		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
Trial Start Date		2000-04-01
Registered in ClinicalTrials.gov		NCT00006695
Date Submitted to PDQ		2000-09-14
Information Last Verified		2006-09-01
NCI Grant/Contract Number		CA36727

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