Infliximab in Treating Patients With Myelodysplastic Syndrome

NCT00074074 | Completed Phase 2

• 1 other identifier: EORTC-06023
• Study Type: interventional
• Target: 46
• Locations: 6 countries
• Sites: 19

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 II trial to study the effectiveness of infliximab in treating patients who have myelodysplastic syndrome.

Conditions

Myelodysplastic Syndromes

Keywords

refractory anemia with excess blasts; refractory anemia with ringed sideroblasts; refractory anemia; de novo myelodysplastic syndromes; secondary myelodysplastic syndromes; previously treated myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

• Best response as measured by Cheson response criteria

Secondary Outcomes (1)

• Duration of highest grade toxicity as assessed by CTCAE v3.0 after response

Interventions

infliximab BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (19)

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

H. Hartziekenhuis - Roeselaere.

Roeselare, 8800, Belgium

Location

Centre Hospitalier Peltzer-La Tourelle

Verviers, B-4800, Belgium

Location

University Hospital - Olomouc

Olomouc, 775 20, Czechia

Location

Institute of Hematology and Blood Transfusion

Prague, 128 20, Czechia

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Ruprecht - Karls - Universitaet Heidelberg

Heidelberg, D-69117, Germany

Location

Marienhospital Stuttgart

Stuttgart, 70199, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Ospedale San Salvatore

Pesaro, I-61100, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1007 MB, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Ziekenhuis Bronovo

The Hague, 2597AX, Netherlands

Location

Related Publications (2)

• Baron F, Suciu S, Amadori S, Muus P, Zwierzina H, Denzlinger C, Delforge M, Thyss A, Selleslag D, Indrak K, Ossenkoppele G, de Witte T. Value of infliximab (Remicade(R)) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group. Haematologica. 2012 Apr;97(4):529-33. doi: 10.3324/haematol.2011.044347. Epub 2011 Nov 18.

  PMID: 22102701 RESULT

• Baila L, Suciu S, Muus P, et al.: Assessment of two doses of infliximab in patients with low/intermediate risk IPSS myelodysplastic syndrome (MDS): an EORTC leukemia group (LG) randomized phase II trial (06023). [Abstract] Blood 110 (11): A-1456, 2007.

  RESULT

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts; Anemia, Refractory

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Heinz Zwierzina, MD

  Medical University Innsbruck

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: October 1, 2003
• Primary Completion: December 1, 2006
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

CZ (2); DE (3); FR (2); NL (4); IT (1); BE (7)