A Phase II Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin (BSHAP) as Salvage in Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
OBJECTIVES:
- Determine the antitumor activity of pixantrone, cytarabine, methylprednisolone, and
cisplatin in patients with aggressive non-Hodgkin's lymphoma in first relapse.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the validity and safety of this regimen as a mobilization regimen before
high-dose chemotherapy with stem cell support in these patients.
OUTLINE: This is an open-label, multicenter study.
- Salvage therapy: Patients receive pixantrone IV over 1 hour on day 1; cisplatin IV over
30 minutes on days 1-4; methylprednisolone IV over 15-30 minutes on days 1-5; and
cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for 2 courses in
the absence of disease progression or unacceptable toxicity.
After 2 courses of salvage therapy, patients are re-evaluated and treated as follows:
- Complete response (CR) or partial response (PR): Patients with a CR or PR who are
suitable candidates for autologous stem cell transplantation (ASCT) proceed to
mobilization therapy, high-dose chemotherapy, and ASCT. Patients with a CR or PR who
are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6
courses in the absence of disease progression or unacceptable toxicity.
- Stable disease: Patients with stable disease continue to receive salvage therapy for up
to 6 courses. Patients who have a CR or PR after 3-4 courses of salvage therapy and who
are suitable candidates for ASCT proceed to mobilization therapy, high-dose
chemotherapy, and ASCT off study at the investigator's discretion.
- Mobilization therapy (optional regimen; regimen used for mobilization is at the
investigator's discretion): Patients receive rituximab* IV on days 1 and 7;
pixantrone IV over 1 hour on day 2; cisplatin IV over 30 minutes on days 2-5;
cytarabine IV over 2 hours on day 6; and methylprednisolone IV over 15-30 minutes
on days 2-6. Patients also receive filgrastim (G-CSF) subcutaneously once daily
beginning on day 7 and continuing until blood counts recover. Patients receive 1
or more courses of mobilization therapy during which stem cells are harvested.
Patients then proceed to high-dose chemotherapy and subsequent re-infusion of
harvested stem cells.
NOTE: *If this mobilization regimen is used, patients with T-cell lymphoma do not receive
rituximab
- High-dose chemotherapy and ASCT: Patients receive high-dose chemotherapy and ASCT per
institutional standard practice.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Julie M. Vose, MD
Study Chair
University of Nebraska
United States: Federal Government
CDR0000316466
NCT00069966
April 2003
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
North Shore University Hospital | Manhasset, New York 11030 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
Baylor University Medical Center | Dallas, Texas 75246 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Hematology-Oncology Associates of Illinois | Chicago, Illinois 60611-2998 |
Cancer Centers of the Carolinas - Eastside | Greenville, South Carolina 29601 |
Piedmont Hematology-Oncology Associates | Winston-Salem, North Carolina 27103 |
Delaware Clinical & Laboratory Physicians | Newark, Delaware 19713 |
Rocky Mountain Cancer Centers - Denver Midtown | Denver, Colorado 80218 |
Gabrail Cancer Center - Canton Office | Canton, Ohio 44718 |
Pasco, Hernando Oncology Associates, P.A. | New Port Richey, Florida |
Arizona Oncology Associates - Craycroft Road Offices | Tucson, Arizona 85712-2254 |
Rocky Mountain Cancer Centers - Colorado Springs | Colorado Springs, Colorado 80933-1181 |
Cancer Care Associates-West | Oklahoma City, Oklahoma 73112-4414 |
Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax | Fairfax, Virginia 22031 |