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Leukemia

Vorinostat + Chemotherapy for CLL or SLL (PSOC-2401)
A Phase I/II Study of Fludarabine (F), Cyclophosphamide ©), Rituximab ®), and Vorinostat (V) Followed by RV Maintenance Therapy in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small LymphoCtic Lymphoma (SLL)
Status Conditions Phase Study ID
Recruiting Leukemia
Lymphoma
Phase I/II PSOC-2401
NCT00918723
Summary

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, 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, 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. Giving vorinostat together with fludarabine phosphate, cyclophosphamide, and rituximab 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 fludarabine phosphate, cyclophosphamide, and rituximab and to see how well it works in treating patients with previously untreated B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.


Investigator
John Pagel, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Olympic Medical Center, Sequim WA 360-683-9895  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of CD20-positive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), meeting one of the following stage criteria:

    • Stage I or II disease with evidence of disease activity, as defined by the NCI 1996 guidelines
    • Stage III or IV disease
  • Previously untreated disease
  • No known brain or leptomeningeal involvement by malignancy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • PT or INR ≤ 1.5 times upper limit of normal (ULN) (unless receiving therapeutic anticoagulation)
  • PTT ≤ 1.2 times ULN (unless receiving therapeutic anticoagulation)
  • Total bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Potassium normal
  • Magnesium normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective barrier methods of contraception during and for up to 2 months after completion of study therapy
  • No active hemolysis
  • No requirement for sustained transfusion support with blood products
  • No active obstructive hydronephrosis
  • No known HIV infection
  • No active hepatitis B infection, other active viral hepatitis infection, or other active infection
  • No significant systemic illness
  • None of the following conditions:

    • NYHA class III or IV heart disease
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Other serious illness (e.g., acute or chronic graft-versus-host disease) that would preclude study evaluation
    • Congenital long QTc syndrome
  • No other prior malignancy, except for any of the following:

    • Cervical intraepithelial neoplasia
    • Nonmelanoma skin cancer
    • Adequately treated localized prostate cancer with PSA < 1.0 ng/mL
    • Other malignancy for which patient has undergone potentially curative therapy with no evidence of disease for ≥ 5 years and/or is deemed to be at low-risk for recurrence by treating physician
  • No other medical, social, or psychosocial factors that, in the opinion of the investigator, may negatively impact patient compliance or safety

PRIOR CONCURRENT THERAPY:

  • More than 1 week since prior systemic steroids, except if given as maintenance therapy for a non-malignant disease
  • More than 30 days since prior and no concurrent participation in another study using investigational compounds or devices
  • No prior cytotoxic chemotherapy, radiotherapy, immunotherapy, or cytokine therapy for CLL or SLL
  • No prior stem cell or bone marrow transplant
  • No prior HDAC inhibitors (e.g., romidepsin, entinostat, LAQ-824, belinostat, panobinostat, MGCD0103, or HDAC inhibitor CRA-024781)
  • No prior compounds with HDAC inhibitor-like activity (e.g., valproic acid) as antitumor therapy
  • More than 30 days since prior compounds with HDAC inhibitor-like activity for other indications (e.g., valproic acid for epilepsy)
  • No other concurrent HDAC inhibitors (e.g., valproic acid)
  • No other concurrent chemotherapy, radiotherapy, biological therapy, or investigational anticancer therapy
  • Concurrent anti-arrhythmic medications or other medications that would lead to QTc prolongation allowed provided baseline QTc ≤ 500 msec
Last Updated
March 25, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.