A phase I clinical trial to study the safety of treatment with Tipifarnib (ZARNESTRA) combined with Bortezomib (VELCADE) in patients with myelodysplastic syndrome (MDS)

Conditions: myelodysplasia
myelodysplastic syndroom
10018865

Registration Number: NL-OMON30154

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

MDS (including the non-proliferative form of CMML, i.e. CMML with a WBC count < 12,0 x 109) /L with < 30% blast cells in the bone marrow and with < 5% circulating blasts).
IPSS score: Intermediate Risk-2 or High Risk
Age at the time of obtaining informed consent 18 years or older
WHO performance status 0-2

Exclusion Criteria

IPSS score: low risk and intermediate-1 category.
Candidates for allogeneic stem cell transplantation.
Clinical relevant liver (AST/ALT equal to or higer than 1,5 ULN and bilirubin equal to or higher than 2 mg/dl) or renal insufficiency (ECC < 50 %).
Significant vascular, pulmonary, gastrointestinal, endocrine, rheumatologic, or metabolic disturbances.
Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment.
Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 8 weeks before enrollment.
Having received a stem cell transplantation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety (type, frequency, and severity [National Cancer Institute (NCI) Common<br /><br>Terminology Criteria for Adverse Events (CTCAE) version 3.0] of adverse events,<br /><br>and relationship of adverse events to VELCADE in combination with ZARNESTRA)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Effectivity in terms of hematologic improvement, number of patients with a<br /><br>complete or partial response of stable disease, number of patients with a<br /><br>cytogenetic response (all defined according to revised International Working<br /><br>Group Criteria)<br /><br>2) Effects of bortezomib and tipifarnib on ubiquitine and proteasome pathways<br /><br>and apoptotic gene expression profiles (translational research) </p><br>