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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.
After completing study treatment, patients are followed every 2 months for 1 year and then every 6 months for 2 years.
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 | Norris Comprehensive Cancer Center |
Investigator: | Anil Tulpule, MD | 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 |
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 |
Sexually Transmitted Diseases, Viral Methylprednisolone Primary effusion lymphoma Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Prednisolone acetate Etoposide phosphate Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Antibodies, Monoclonal Lymphoma, B-Cell Lymphoma, large-cell Burkitt's lymphoma Cisplatin Lymphoma, AIDS-Related |
Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Etoposide Retroviridae Infections Lymphoma Cytarabine Methylprednisolone Hemisuccinate Immunoglobulins Lymphoma, AIDS-related Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Acquired Immunodeficiency Syndrome Methylprednisolone acetate |
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Slow Virus Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Neuroprotective Agents Therapeutic Uses RNA Virus Infections |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Gastrointestinal Agents Glucocorticoids Protective Agents Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Autonomic Agents Lentivirus Infections Peripheral Nervous System Agents Antirheumatic Agents |