Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

NCT00118287 | Completed Phase 1 Results DMC

• 2 other identifiers: 1926.00NCI-2011-01818
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy

Conditions

de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Secondary Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria

  Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.

  Up to 2 years

Study Arms (1)

Treatment (chemotherapy, chemoprotection)

EXPERIMENTAL

Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: azacitidine; Biological: etanercept

Interventions

azacitidine DRUG

Given SC or IV

Also known as: 5-AC, 5-azacytidine, azacytidine, Vidaza

Treatment (chemotherapy, chemoprotection)

etanercept BIOLOGICAL

Given SC

Also known as: Enbrel, ETN, TNFR:Fc, Tumor Necrosis Factor Receptor IgG Chimera

Treatment (chemotherapy, chemoprotection)

Eligibility Criteria

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

You may qualify if:

• Int-2 or high risk MDS patients
• Patients with low-risk or int-1 risk MDS by International Prognostic Scoring System (IPSS) criteria with:
• Single or multilineage cytopenia (absolute neutrophil count \[ANC\] \< 1500/μL, hemoglobin \[Hgb\],10g/dL, or platelet count \< 100,000/μL); or
• Transfusion requirement of at least 2 units of packed red blood cells over an 8 week period
• Serum creatinine =\< 1.5x ULN (upper limit of normal)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2x ULN
• Performance status =\< 2 (Eastern Cooperative Oncology Group \[ECOG\] scale, 0-5)

You may not qualify if:

• Patients who have previously received hematopoietic stem cell transplants, specifically for MDS
• Patients with a diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria (i.e \>= 20% blasts) at time of enrollment
• Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
• Men who are unwilling to use contraception while receiving 5-aza
• Patients with severe disease other than MDS which is expected to prevent compliance with the present protocol
• Patients with severe infections (pneumonia, septicemia, etc) within the 2 weeks prior to the anticipated start of protocol treatment
• Patients who are currently receiving or within the preceding 2 weeks have received cytotoxic therapy, hemopoietic growth factors, immunomodulatory therapy, or other experimental therapy for the treatment of MDS
• Current evidence of uncontrolled cardiac arrhythmia or congestive heart failure
• Platelet count =\< 10,000/mcl
• Absolute neutrophil count =\< 250/mcl
• Prior treatment with 5-aza
• Known or suspected hypersensitivity to azacitidine or mannitol

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Azacitidine; Etanercept

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Bart Scott
• Organization: Fred Hutchinson Cancer Research Center

bscott@fredhutch.org

206-667-1990

Study Officials

• Bart Scott

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: April 1, 2005
• Primary Completion: October 1, 2008
• Last Updated: May 24, 2017
• Results First Posted: May 24, 2017

Record last verified: 2017-04

Locations

US (1)