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Sponsors and Collaborators: |
Puget Sound Oncology Consortium at Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601718 |
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, 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. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with rituximab and combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well they work in treating patients with relapsed or primary refractory lymphoma or previously untreated T-cell non-Hodgkin lymphoma or mantle cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: filgrastim Biological: pegfilgrastim Biological: rituximab Drug: carboplatin Drug: etoposide Drug: ifosfamide Drug: vorinostat |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of Vorinostat Plus Rituximab, Ifosphamide, Carboplatin, and Etoposide for Patients With Relapsed or Refractory Lymphoid Malignancies or Untreated T- or Mantle Cell Lymphoma |
Estimated Enrollment: | 21 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of vorinostat.
Patients receive oral vorinostat once daily on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients also receive pegfilgrastim subcutaneously (SC) once on day 6 or 7 OR filgrastim (G-CSF) SC once daily beginning on day 6 or 7 and continuing until blood counts recover. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of previously untreated T-cell non-Hodgkin lymphoma or mantle cell lymphoma OR relapsed or primary refractory lymphoid malignancy, including the following types:
Measurable disease, defined as any of the following:
PATIENT CHARACTERISTICS:
No other medical condition that would contraindicate treatment with aggressive chemotherapy, including any of the following:
No history of impaired cardiac status, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 |
Principal Investigator: | Elizabeth Pan | Seattle Cancer Care Alliance |
Investigator: | Ajay K. Gopal, MD | Seattle Cancer Care Alliance |
Investigator: | John Pagel, MD, PhD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Seattle Cancer Care Alliance ( Elizabeth Pan ) |
Study ID Numbers: | CDR0000584894, PSOC-2302, FHCRC-IR-6632 |
Study First Received: | January 24, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00601718 History of Changes |
Health Authority: | Unspecified |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult Hodgkin lymphoma recurrent adult T-cell leukemia/lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma cutaneous B-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma |
recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent mantle cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma recurrent small lymphocytic lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage I mantle cell lymphoma stage II mantle cell lymphoma stage III mantle cell lymphoma |
Anticarcinogenic Agents Anti-Inflammatory Agents Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Etoposide Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Carboplatin Waldenstrom Macroglobulinemia |
B-cell Lymphomas Leukemia, T-Cell Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Lymphoma, T-Cell, Cutaneous Immunologic Factors Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Sezary Syndrome Mycosis Fungoides Lymphoblastic Lymphoma Etoposide phosphate Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs Etoposide phosphate Sensory System Agents Lymphoma, T-Cell Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Etoposide Lymphoma |
Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Rituximab Vorinostat Enzyme Inhibitors Carboplatin Protective Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Ifosfamide Analgesics, Non-Narcotic Peripheral Nervous System Agents |