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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


Phase 2
19 Years
70 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

event free survival rate

Outcome Time Frame:

100 days post transpat and at yearly intervals

Safety Issue:

No

Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska

Authority:

United States: Food and Drug Administration

Study ID:

051-00

NCT ID:

NCT00006695

Start Date:

April 2000

Completion Date:

January 2015

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680