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Status:

COMPLETED

Infliximab in Treating Patients With Myelodysplastic Syndrome

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Myelodysplastic Syndromes

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as infliximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Randomized phase I...

Detailed Description

OBJECTIVES: * Determine the therapeutic activity of 2 different doses of infliximab on peripheral blood cell count and peripheral and bone marrow blast cell count in patients with low- or intermediat...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Confirmed diagnosis (within the past month) of low- or intermediate-risk myelodysplastic syndromes (MDS) meeting all of the following criteria:
  • No more than 10% bone marrow blasts (corresponding to refractory anemia \[RA\], RA with ringed sideroblasts, or RA with excess blasts)
  • Meets at least 1 of the following hematopoietic criteria:
  • Hemoglobin no greater than 10 g/dL OR red blood cell transfusion dependent
  • Neutrophil count no greater than 1,500/mm\^3
  • Platelet count no greater than 100,000/mm\^3 OR platelet transfusion dependent
  • No poor cytogenetics (complex abnormalities or involvement of chromosome 7)
  • Patients with unknown cytogenetics may be eligible provided reasonable efforts have been made for determining the cytogenetic profile and the results are considered a failure (e.g., normal karyotype \[NN\] with no more than 10 metaphases)
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • WHO 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • See Disease Characteristics
  • Hepatic
  • No history of documented hepatitis C
  • No documented active hepatitis B
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT less than 2.5 times ULN
  • Renal
  • Creatinine less than 1.5 times ULN
  • Cardiovascular
  • No New York Heart Association class III or IV heart disease
  • No clinical history or evidence of congestive heart failure
  • No severe cardiac dysfunction
  • LVEF greater than 35%
  • Pulmonary
  • No prior or concurrent active or latent tuberculosis (TB)
  • No evidence of prior or concurrent active TB (i.e., fibrotic or pleural scarring, pulmonary nodules, mediastinal and/or hilar lymphadenopathy, upper lobe volume loss, or cavitation) by chest x-ray
  • Negative intradermal tuberculin skin test (i.e., induration less than 5 mm)
  • No severe pulmonary dysfunction
  • Immunologic
  • No prior or concurrent opportunistic infection (e.g., herpes zoster, cytomegalovirus, Pneumocystic carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within the past 6 months
  • No concurrent severe (CTC grade III or IV) active, chronic, or recurrent infections
  • No recent history of allergies
  • HIV negative
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • No prior clinically significant adverse event to murine or chimeric proteins or human/murine recombinant products
  • No recent contact with an individual with active TB
  • No poor medical risk due to other systemic disease
  • No multiple sclerosis or other demyelinating disorder
  • No peripheral neuropathy greater than CTC grade 1
  • No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior infliximab or other monoclonal antibodies
  • At least 6 weeks since prior hematopoietic growth factors for MDS
  • At least 3 months since prior therapy targeted at reducing tumor necrosis factor (TNF) alpha (e.g., pentoxifylline, thalidomide, or etanercept)
  • No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
  • No other concurrent drugs targeted at reducing TNF alpha (e.g., pentoxifylline, thalidomide, or etanercept)
  • Chemotherapy
  • Not specified
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Surgery
  • No prior solid organ transplantation
  • Corneal transplantation more than 3 months ago allowed
  • Other
  • No prior randomization to this clinical trial
  • At least 6 weeks since prior treatment for MDS (except supportive care)
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent therapeutic-dose nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Concurrent sporadic (no more than 3 tablets/week) over-the-counter NSAIDs allowed
  • Concurrent cardioprotective doses (80 mg/day or equivalent) of aspirin allowed

Exclusion

    Key Trial Info

    Start Date :

    October 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    46 Patients enrolled

    Trial Details

    Trial ID

    NCT00074074

    Start Date

    October 1 2003

    Last Update

    July 16 2012

    Active Locations (19)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (19 locations)

    1

    AZ Sint-Jan

    Bruges, Belgium, 8000

    2

    Institut Jules Bordet

    Brussels, Belgium, 1000

    3

    Hopital Universitaire Erasme

    Brussels, Belgium, 1070

    4

    Universitair Ziekenhuis Antwerpen

    Edegem, Belgium, B-2650