Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse
|ClinicalTrials.gov Identifier: NCT00069966|
Recruitment Status : Unknown
Verified November 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 7, 2003
Last Update Posted : July 7, 2009
RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone, and cisplatin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed aggressive non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: filgrastim Biological: rituximab Drug: cisplatin Drug: cytarabine Drug: methylprednisolone Drug: pixantrone dimaleate Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||April 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069966
Hide Study Locations
|United States, Arizona|
|Arizona Oncology Associates - Craycroft Road Offices|
|Tucson, Arizona, United States, 85712-2254|
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|United States, Colorado|
|Rocky Mountain Cancer Centers - Colorado Springs|
|Colorado Springs, Colorado, United States, 80933-1181|
|Rocky Mountain Cancer Centers - Denver Midtown|
|Denver, Colorado, United States, 80218|
|United States, Delaware|
|Delaware Clinical & Laboratory Physicians|
|Newark, Delaware, United States, 19713|
|United States, Florida|
|Pasco, Hernando Oncology Associates, P.A.|
|New Port Richey, Florida, United States, 34652|
|United States, Illinois|
|Hematology-Oncology Associates of Illinois|
|Chicago, Illinois, United States, 60611-2998|
|United States, Kentucky|
|Markey Cancer Center at University of Kentucky Chandler Medical Center|
|Lexington, Kentucky, United States, 40536-0084|
|United States, Louisiana|
|Louisiana State University Health Sciences Center - Shreveport|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-7680|
|United States, New York|
|North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|SUNY Upstate Medical University Hospital|
|Syracuse, New York, United States, 13210|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Piedmont Hematology-Oncology Associates|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Ohio|
|Gabrail Cancer Center - Canton Office|
|Canton, Ohio, United States, 44718|
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University|
|Cleveland, Ohio, United States, 44106-5055|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Oklahoma|
|Cancer Care Associates-West|
|Oklahoma City, Oklahoma, United States, 73112-4414|
|United States, Oregon|
|Providence Cancer Center at Providence Portland Medical Center|
|Portland, Oregon, United States, 97213|
|United States, Pennsylvania|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|United States, South Carolina|
|Cancer Centers of the Carolinas - Eastside|
|Greenville, South Carolina, United States, 29615|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax|
|Fairfax, Virginia, United States, 22031|
|United States, Wisconsin|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226-3596|
|Hospital Auxilio Mutuo|
|Hato Rey, Puerto Rico, 00918|
|Study Chair:||Julie M. Vose, MD||University of Nebraska|