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Sponsors and Collaborators: |
AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00310128 |
RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and cisplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving more than one drug (combination chemotherapy) together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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AIDS-Related Lymphoma Adult Non-Hodgkin's Lymphoma Anaplastic Large Cell Lymphoma |
Drug: cisplatin Drug: cytarabine Drug: etoposide Drug: methylprednisolone Drug: rituximab Drug: yttrium Y 90 ibritumomab tiuxetan Procedure: antibody therapy Procedure: biological therapy Procedure: chemotherapy Procedure: monoclonal antibody therapy Procedure: radiation therapy Procedure: radioimmunotherapy Procedure: radioisotope therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Induction Therapy Comprising Etoposide, Methylprednisolone, Cytarabine, and Cisplatin (ESHAP) Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Alexandra M. Levine, MD | USC/Norris Comprehensive Cancer Center |
Investigator: | Anil Tulpule, MD | USC/Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000467797, AMC-044 |
Study First Received: | March 29, 2006 |
Last Updated: | October 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00310128 History of Changes |
Health Authority: | United States: Federal Government |
AIDS-related diffuse large cell lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related small noncleaved cell lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related immunoblastic large cell lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma |
stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma contiguous stage II adult Burkitt's lymphoma noncontiguous stage II adult Burkitt's lymphoma recurrent adult Burkitt's lymphoma stage I adult Burkitt's lymphoma stage III adult Burkitt's lymphoma stage IV adult Burkitt's lymphoma anaplastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma recurrent adult diffuse large cell lymphoma stage I adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
Anti-Inflammatory Agents Anti-Infective Agents Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Follicular Lymphoma Lymphoma, AIDS-Related Lymphoma, Large-Cell, Anaplastic Etoposide Immunoglobulins Methylprednisolone Hemisuccinate Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Antineoplastic Agents, Hormonal Rituximab Acquired Immunodeficiency Syndrome Glucocorticoids Virus Diseases B-cell Lymphomas HIV Infections Primary Effusion Lymphoma Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites Sexually Transmitted Diseases, Viral Immunologic Factors Lymphoma, Follicular Prednisolone acetate |
Anti-Inflammatory Agents Anti-Infective Agents Slow Virus Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Lymphoma, AIDS-Related Therapeutic Uses Lymphoma, Large-Cell, Anaplastic Etoposide Methylprednisolone Hemisuccinate |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Acquired Immunodeficiency Syndrome Glucocorticoids Virus Diseases Neoplasms HIV Infections Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites Sexually Transmitted Diseases, Viral Immunologic Factors |