Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Non-Hodgkin's Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2000

Primary Completion Date

September 1, 2005

Study Completion Date

December 16, 2014

Conditions
Lymphoma
Interventions
DRUG

carmustine

300 mg/m2 IV on Day -6

DRUG

cytarabine

100 mg/m2 BID on Days -5 through -2

DRUG

etoposide

100 mg/m2 BID on Days -5 through -2

DRUG

melphalan

140 mg/m2 IV on Day -1

PROCEDURE

peripheral blood stem cell transplantation

Following the chemotherapy, on Day 0 of treatment, the previously stored hematopoietic stem cells will be administered to the patient intravenously through a central line to the patient.

RADIATION

tositumomab and iodine I 131 tositumomab

"Patients will receive two administrations of Iodine-131 Anti-B1 Antibody; the dosimetric dose and the therapeutic dose. The dosimetric dose will consist of an infusion of unlabeled Anti-B1 Antibody (450 mg) immediately followed by an infusion of Anti-B1 Antibody (35 mg) which has been trace labeled with 5 mCi of Iodine-131 Anti-B1 Antibody. Using whole body anterior and posterior gamma camera scans and serial imaging studies over approximately one week, the clearance of the whole body dosimetric dose will be used to calculate the subsequent therapeutic dose of Iodine-131 Anti-B1 Antibody which delivers a total body dose of 75 cGy to the subject"

Trial Locations (1)

68198-6805

UNMC Eppley Cancer Center at University of Nebraska Medical Center, Omaha

All Listed Sponsors
lead

University of Nebraska

OTHER

NCT00006695 - Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Non-Hodgkin's Lymphoma | Biotech Hunter | Biotech Hunter