2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)

NCT00483067 | Completed Phase 2

• 1 other identifier: DM97-232
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.To determine the response rate, progression-free survival (PFS) and overall survival of patients who receive 2-CdA + Ara-C.
2. 2.To examine if there is any clonality in the cytokine expression of helper T cells or cytokine receptor expression of eosinophils.
3. 3.To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.

Conditions

Leukemia

Keywords

Idiopathic Hypereosinophilic Syndrome; Leukemia; 2-Chlorodeoxyadenosine; Cladribine; Cytarabine; Ara-C; 2-CdA; G-CSF; HES

Outcome Measures

Primary Outcomes (1)

• Patient Outcomes at 6 Weeks

  Patient outcomes defined at 6 weeks as Complete Remission (CR), absolute eosinophil count less than 1,500/mm3 and less than 5% of eosinophilic infiltrates in the bone marrow; and PR (partial response) defined as major clinical improvement without meeting the criteria specified for CR including an improvement in performance status to Zubrod's 0 or 1 along with clearance of clinical signs and symptoms of disease that are present at baseline.

  Baseline to 6 weeks timepoint (day 42)

Study Arms (1)

2-CdA + Ara-C + G-CSF

EXPERIMENTAL

2-CdA 12 mg/m\^2/day by vein (IV) Continuous Infusion and Ara-C 1 gm/m\^2/day IV for 5 Days with G-CSF 5 mcg/kg/day subcutaneously starting Day 9

Drug: 2-CdA; Drug: Ara-C; Drug: G-CSF (Granulocyte colony-stimulating factor)

Interventions

2-CdA DRUG

12 mg/m\^2/day by vein (IV) Continuous Infusion x 5 Days

Also known as: 2-Chlorodeoxyadenosine, Cladribine

2-CdA + Ara-C + G-CSF

Ara-C DRUG

1 gm/m\^2/day IV Over 2 Hours x 5 Days

Also known as: Cytarabine

2-CdA + Ara-C + G-CSF

G-CSF (Granulocyte colony-stimulating factor) DRUG

5 mcg/kg/day given under the skin (subcutaneously) starting Day 9

Also known as: Filgrastim, Neupogen, Granulocyte colony-stimulating factor, GCSF

2-CdA + Ara-C + G-CSF

Eligibility Criteria

• Age: Up to 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have diagnosis of idiopathic HES, defined as (1) no recent history of allergic reaction or parasitic infection; (2) sustained (\> 6 months) hypereosinophilia (1,500/mm\^3); and (3) signs or symptoms of organ involvement.
• Age less than 76 years old.
• Patient is not pregnant.
• Zubrod performance status \< 3.
• Life expectancy is not severely limited by concomitant illness.
• Serum creatinine \< 2 mg/dL.
• Serum bilirubin \< 2 times upper limit of normal (2 mg/dL).
• Alanine aminotransferase (SGPT) \< 2 times upper limit of normal (112 IU/L).
• Participant has completed the informed consent process, understands the investigational nature of the study, agrees to participate, and has signed the informed consent.

You may not qualify if:

• Evidence of chronic active hepatitis or cirrhosis, and \> 1 month from prior episode of hepatitis.
• Presence of an active infection.
• HIV positive.
• Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
• Recent history of parasite infection.
• Recent history of allergic reaction.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia; Hypereosinophilic Syndrome

Interventions

Cladribine; Cytarabine; Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Eosinophilia; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Michael Andreeff, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 6, 2007
• Study Start: March 1, 1998
• Primary Completion: March 1, 2006
• Study Completion: July 1, 2008
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)