|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Theradex |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00069966 |
Purpose
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 | Intervention | 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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, 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 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
After 2 courses of salvage therapy, patients are re-evaluated and treated as follows:
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.
NOTE: *If this mobilization regimen is used, patients with T-cell lymphoma do not receive rituximab
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)
The following subtypes are eligible:
At least 1 measurable lesion
No chemotherapy-refractory disease, defined as follows:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
No history or clinical symptoms of hepatitis B or hepatitis C virus
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Recovered from prior therapy
Contacts and Locations
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 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| 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 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| 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 | |
| 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 | |
| Puerto Rico | |
| Hospital Auxilio Mutuo | |
| Hato Rey, Puerto Rico, 00918 | |
| Study Chair: | Julie M. Vose, MD | University of Nebraska |
More Information
| Study ID Numbers: | CDR0000316466, THERADEX-AZA-II-02, CWRU-NOVU-1403, SUNY-HSC-4849, NOVUSPHARMA-AZA-II-02 |
| Study First Received: | October 3, 2003 |
| Last Updated: | July 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00069966 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult diffuse large cell lymphoma anaplastic large cell lymphoma recurrent adult diffuse mixed cell lymphoma |
recurrent adult immunoblastic large cell lymphoma recurrent grade 3 follicular lymphoma recurrent adult Burkitt lymphoma |
|
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Cisplatin |
Therapeutic Uses Lymphoma Cytarabine Methylprednisolone Hemisuccinate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Gastrointestinal Agents Methylprednisolone acetate Glucocorticoids Protective Agents Immunosuppressive Agents Antiviral Agents |