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Clinical Trial Name - Vorinostat, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed o
| Original Study ID : CDR0000584894 |
| Secondary ID : Array |
| NCT ID : NCT00601718 |
| Brief Title : Vorinostat, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Primary Refractory Lymphoma or Previously Untreated T-Cell Non-Hodgkin Lymphoma or Mantle Cell Lymphoma |
| 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 |
| Brief Summary : 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. |
| Source : National Cancer Institute (NCI) |
| Detailed Description : OBJECTIVES: - To determine the maximum tolerated dose of vorinostat when administered in combination with rituximab, ifosfamide, carboplatin, and etoposide in patients with relapsed or primary refractory lymphoid malignancies or previously untreated T-cell non-Hodgkin lymphoma or mantle cell lymphoma. - To determine the safety and toxicity of this regimen. - To gain a preliminary assessment of the efficacy of this regimen. - To determine the ability to proceed to peripheral blood stem cell collection following treatment with this regimen. - To determine the impact of this regimen on stem cell reserve 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. |
| Overall Status : Recruiting |
| Start Date : March 2008 |
| Official Title : Phase 1/Phase 2 |
| Phase : Interventional |
| Study Design : Treatment |
| Enrollment : 21 |
| Verification Date : April 2009 |
| First Received Date : January 24, 2008 |
| Trial Eligibility |
| Criteria : 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: - B-cell lymphoma - T-cell lymphoma - Hodgkin lymphoma - Patients with other lymphomas that have not received any prior therapy AND are not candidates for anthracycline-based therapies are eligible with Principle Investigator review and approval - Measurable disease, defined as any of the following: - Lesions that can be accurately measured in two dimensions by CT scan, MRI, medical photograph (skin or oral lesion), plain x-ray, or other conventional technique AND a greatest transverse diameter of ≥ 1 cm - Palpable lesions with both diameters ≥ 2 cm - No disease refractory (i.e., not responded or progressed within the past 6 months) to a carboplatin-, cisplatin-, ifosfamide-, or etoposide-based regimen - Patients with evidence of adenopathy in the neck must have a CT scan of the neck - Must be able to complete at least 2 courses of chemotherapy - No active CNS lymphoma PATIENT CHARACTERISTICS: - SWOG performance status 0-2 - ANC ≥ 1,500/mm³ - Platelets ≥ 100,000/mm³ (without transfusion) - Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min - Total bilirubin < 1.5 times upper limit of normal (ULN) - AST < 5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known HIV positivity - No other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for ≥ 5 years unless approved by the protocol Chair or Co-Chair - No other medical condition that would contraindicate treatment with aggressive chemotherapy, including any of the following: - Active infection - Uncontrolled hypertension - Congestive heart failure - Unstable angina pectoris - Myocardial infarction within the past 6 months - Uncontrolled arrhythmia - No history of impaired cardiac status, including any of the following: - Severe coronary artery disease - Cardiomyopathy - Congestive heart failure - Arrhythmia - No arrhythmias on EKG (sinus arrhythmia or infrequent premature ventricular contractions allowed) - LVEF ≥ 50% by MUGA or ECHO PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 28 days since prior anticancer therapy - More than 12 months since prior autologous or allogeneic stem cell transplantation - More than 6 months since prior radioimmunotherapy - More than 2 weeks since prior and no concurrent valproic acid - No other prior or concurrent histone deacetylase inhibitors - No other concurrent therapy intended to treat the primary cancer including chemotherapy, investigational agents, biologic agents, or other antitumor agents - No concurrent radiotherapy |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Seattle Cancer Care Alliance |
| Status : Recruiting |
| City : Seattle |
| State : Washington |
| Zip Code : 98109-1023 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Interventions |
| Type : Biological |
| Name : filgrastim |
| Type : Biological |
| Name : pegfilgrastim |
| Type : Biological |
| Name : rituximab |
| Type : Drug |
| Name : carboplatin |
| Type : Drug |
| Name : etoposide |
| Type : Drug |
| Name : ifosfamide |
| Type : Drug |
| Name : vorinostat |
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