A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkin's Lymphoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Corixa Corporation
Study ID
NCT00078598
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe. Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada - Rituxan®; EU - Mabthera®), given as an IV infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the "dosimetric dose," patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0, Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from these three imaging timepoints, the patient's weight, and platelet count, a patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second phase, termed the "therapeutic dose," patients in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered activity of Iodine 131-conjugated Tositumomab (35 mg). Patients on study will be followed for response and safety at Week 7, Week 13, and every 3 months for the first and second years, every 6 months for the third year, and then annually for the fourth and fifth years. Patients will be followed for safety only annually for years 6-10.

Key Dates

Start date
Apr 30, 2004
Status verified
Oct 2004

Study Design

Enrollment
506 participants
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Locations (5)

FacilityCityStateZIPSite coordinators
Northside HospitalAtlantaGeorgia30342
Barry Boatman, RN
[email protected]
404-303-3355
Ronald Steis, MD (PRINCIPAL_INVESTIGATOR)
Medical Oncology/Hematology AssociatesDaytonOhio45409
Cathy Hull, RN
937-223-2183
Basel Yanes, MD (PRINCIPAL_INVESTIGATOR)
Madigan Army Medical CenterTacomaWashington98431
Carol Dean, RN
[email protected]
253-968-3681
David E McCune, MD, MPH (PRINCIPAL_INVESTIGATOR)
St Mary Medical Center/Regional Cancer CenterWalla WallaWashington99362
Cathy McCauley, RN
[email protected]
509-522-5993
Matthew Sacks, MD (PRINCIPAL_INVESTIGATOR)
West Virginia University/Mary Babb Randolph Cancer CenterMorgantownWest Virginia26506
Robin Weisenborn, MT, CCRC
[email protected]
304-293-3709
Solveig Ericson, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Northside Hospital· Atlanta, GAMedical Oncology/Hematology Associates· Dayton, OHMadigan Army Medical Center· Tacoma, WASt Mary Medical Center/Regional Cancer Center· Walla Walla, WAWest Virginia University/Mary Babb Randolph Cancer Center· Morgantown, WV

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