Vorinostat, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Lymphoma or Previously Untreated T-Cell Non-Hodgkin Lymphoma or Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00601718|
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : May 25, 2017
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Contiguous Stage II Mantle Cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma 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 Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage I Mantle Cell Lymphoma Stage I Mycosis Fungoides/Sezary Syndrome Stage II Cutaneous T-cell Non-Hodgkin Lymphoma Stage II Mycosis Fungoides/Sezary Syndrome Stage III Cutaneous T-cell Non-Hodgkin Lymphoma Stage III Mantle Cell Lymphoma Stage III Mycosis Fungoides/Sezary Syndrome Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Mycosis Fungoides/Sezary Syndrome Waldenström Macroglobulinemia||Drug: vorinostat Biological: rituximab Drug: ifosfamide Drug: carboplatin Drug: etoposide Other: pharmacological study Other: laboratory biomarker analysis Genetic: gene expression analysis||Phase 1 Phase 2|
I. To determine maximally tolerated dose of vorinostat that can be combined with RICE chemotherapy in patients with relapsed lymphoid malignancies.
II. To determine the safety and toxicity of the above regimen. III. To gain a preliminary assessment of the efficacy of the above regimen. IV. To determine the ability to proceed to peripheral blood stem cell collection following the above regimens (the impact of above regimen on stem cell reserve).
V. To describe vorinostat concentration attained at or near the MTD. VI. To evaluate the change of histone acetylation patterns and pro-apoptotic proteins of primary target (tumor) and non-target peripheral blood mononuclear cells (PBMC) cells following high-dose HDAC inhibition.
VII. To describe the gene expression profile changes of tumor and non-tumor cells following high-dose HDAC inhibition.
OUTLINE: This is a phase I/II dose-escalation study of vorinostat.
Patients receive vorinostat orally (PO) once daily (QD) 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 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 up every 3 months for 1 year and then every 6 months for 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2010|
Experimental: Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
Patients receive vorinostat PO QD 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 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.
Other Names:Biological: rituximab
Other Names:Drug: ifosfamide
Other Names:Drug: carboplatin
Other Names:Drug: etoposide
Other Names:Other: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
Correlative studiesGenetic: gene expression analysis
- Maximum Tolerated Dose of Vorinostat [ Time Frame: 28 days post last dose of study drug ]
- Safety and Toxicity According to CTCAE v3.0 [ Time Frame: 3-5 weeks post end of treatment ]Common dose limiting toxicities.
- Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy [ Time Frame: 3-5 weeks post end of treatment ]
- Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment [ Time Frame: 1-3 weeks post end of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601718
|United States, Washington|
|Puget Sound Oncology Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Lihua Budde||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|