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| 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: | Masking: Open Label Primary Purpose: Treatment |
| 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
Show 29 Study Locations| Study Chair: | Julie M. Vose, MD | University of Nebraska |
More Information
| ClinicalTrials.gov Identifier: | NCT00069966 History of Changes |
| Other 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 |
| 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 |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Pixantrone Rituximab Cisplatin Cytarabine Methylprednisolone Hemisuccinate Prednisolone Lenograstim |
Methylprednisolone acetate Prednisolone acetate Methylprednisolone Prednisolone phosphate Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunosuppressive Agents |