Radiolabeled Monoclonal Antibody Therapy and High-Dose Chemotherapy Followed By Autologous Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

April 30, 2000

Primary Completion Date

June 30, 2006

Study Completion Date

March 31, 2009

Conditions
Lymphoma
Interventions
BIOLOGICAL

filgrastim

Given at a dose of 5 μg/kg, subcutaneously daily, beginning on Day 0 (stem cell transplant day) until white blood cells measure greater than 1500/ul.

BIOLOGICAL

rituximab

Intravenous infusion of 250 mg/m2 on treatment days -22 and -14 (day 0 = stem cell transplant).

DRUG

Carmustine

Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Carmustine is given at a dose of 300 mg/m2 intravenous infusion over a 2 hour period on treatment day -6 (Day 0 = stem cell transplant).

DRUG

cytarabine

Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Cytarabine is given at a dose of 100 mg/m2 intravenous infusion over a 1 hour period, every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).

DRUG

etoposide

Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Etoposide is given at a dose of 100 mg/m2 intravenous infusion over a 2 hour period every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).

DRUG

melphalan

Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Melphalan is given at a dose of 140 mg/m2 as an intravenous infusion over a 1 hour period on treatment day -1 (Day 0 = stem cell transplant).

PROCEDURE

peripheral blood stem cell transplantation

On day 0, a minimum of 2.0 X 106 CD34+ cells/kg unselected peripheral blood progenitor cells (PBPC) will be reinfused following institutional guidelines for the reinfusion procedure.

RADIATION

yttrium Y 90 ibritumomab tiuxetan

Patients will receive 90Y2B8 at a variable dose on treatment day -14 (Day 0 = stell cell transplant). The initial dose calculated to deliver no more than 100 cGy to critical organs (liver, lung). Doses will be escalated based on cohort of enrollment.

Trial Locations (3)

55905

Mayo Clinic Cancer Center, Rochester

60611-2998

Hematology-Oncology Associates of Illinois, Chicago

60611-3013

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Northwestern University

OTHER

NCT00058292 - Radiolabeled Monoclonal Antibody Therapy and High-Dose Chemotherapy Followed By Autologous Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma | Biotech Hunter | Biotech Hunter