Phase 2
N=29
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
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
Bottom Line
View on ClinicalTrials.gov: NCT00601718 ↗Enrolled (actual)
29
Serious AEs
34.5%
Results posted
May 2017
Primary outcome: Primary: Maximum Tolerated Dose of Vorinostat — 500 mg twice daily X 5 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- vorinostat (Drug); rituximab (Biological); ifosfamide (Drug); carboplatin (Drug); etoposide (Drug); pharmacological study (Other); laboratory biomarker analysis (Other); gene expression analysis (Genetic)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Vorinostat |
500 | — |
| PRIMARY Safety and Toxicity According to CTCAE v3.0 |
2; 2; 2; 9 | — |
| PRIMARY Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy |
19 | — |
| PRIMARY Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment |
20 | — |
Summary
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 refractory lymphoma or previously untreated T-cell non-Hodgkin lymphoma or mantle cell lymphoma. 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
Eligibility Criteria
Inclusion Criteria
- Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkins disease), or untreated T-NHL or MCL
- Patients with other lymphomas that have not received any prior therapy and are not candidates for anthracycline-based therapies, are eligible with PI review and approval
- Revised European American classification (REAL), or World Health Organization (WHO) classification of patient's malignancies must be provided
- Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters >= 2 cm
- Patients must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy
- Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of neck
- Patients should not have evidence of active central nervous system lymphoma
- Electrocardiogram (EKG) must be free of any arrhythmias (excluding sinus arrhythmia or infrequent premature ventricular contractions)
- Patients must have a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Serum creatinine = 100,000/mm^3 (without transfusion)
Exclusion Criteria
- Patients known to be human immunodeficiency virus (HIV) positive
- Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other cancer from which the patient has been disease free for 5 years or greater, unless approved by the protocol Chair or Co-Chair
- Patients that are refractory (i.e. not responded or progressed within 6 months) to a carboplatin, cisplatin, ifosfamide, or etoposide-based regimen-based regimen
- Patients that have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, or uncontrolled arrhythmia)
- Patients with a history of impaired cardiac status (including history of severe coronary artery disease, cardiomyopathy, congestive heart failure or arrhythmia); if the patient's history is questionable, a measurement of left ventricular ejection fraction should be obtained within 42 days prior to registration; patients with left ventricular ejection fraction < 50% are not eligible
- Autologous or allogeneic transplantation within 12 months or radioimmunotherapy within 6 months of registration
- No concurrent treatment with valproic acid or on valproic acid within 2 weeks of study enrollment
- No prior treatment with histone deacetylase inhibitors
- No concurrent therapy for this malignancy
Data sourced from ClinicalTrials.gov (NCT00601718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.