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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00483067
First received: June 5, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Primary Objectives:

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

Condition Intervention Phase
Leukemia
Drug: 2-CdA
Drug: Ara-C
Drug: G-CSF (Granulocyte colony-stimulating factor)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study: 2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Outcomes at 6 Weeks [ Time Frame: Baseline to 6 weeks timepoint (day 42) ] [ Designated as safety issue: No ]
    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.


Enrollment: 13
Study Start Date: March 1998
Study Completion Date: July 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2-CdA + Ara-C + G-CSF
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
12 mg/m^2/day by vein (IV) Continuous Infusion x 5 Days
Other Names:
  • 2-Chlorodeoxyadenosine
  • Cladribine
Drug: Ara-C
1 gm/m^2/day IV Over 2 Hours x 5 Days
Other Name: Cytarabine
Drug: G-CSF (Granulocyte colony-stimulating factor)
5 mcg/kg/day given under the skin (subcutaneously) starting Day 9
Other Names:
  • Filgrastim
  • Neupogen
  • Granulocyte colony-stimulating factor
  • GCSF

Detailed Description:

Before the study begins, patients will have a physical exam, blood tests, and urine tests. Women will have a pregnancy test. A bone marrow sample will be taken. This is done with a large needle. Heart tests and an MRI scan of the brain will be done if there is a suspicion of disease in the heart or central nervous system.

Patients in this study must have a catheter (thin tube) placed in a vein in the arm or under the collarbone. This tube will be left in place throughout the study. 2-CdA (Cladribine) will be given through the catheter 24 hours a day on days 2 to 6. Ara-C (Cytarabine) will be given through the catheter over 2 hours on days 1, 3, 4, 5, and 6. Starting on day 9, patients will inject G-CSF under their skin once a day; G-CSF helps blood counts return to normal. Treatment will be given on an inpatient or outpatient basis. The first course is normally done inpatient.

During the study, patients will have blood tests daily during the first week and every other day after that. Bone marrow samples will be taken on days 14, 21, and 28. Further bone marrow samples may be necessary to evaluate response. Heart tests and MRI scans of the brain may be done.

This is an investigational study. G-CSF, 2-CdA, and Cytarabine are approved by the FDA for treatment of cancer. Up to 40 patients will take part in this study. Patients will be treated at M. D. Anderson or other centers. A total of 40 people will take part in this study. About 1 patient every 3 months will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   up to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Age less than 76 years old.
  3. Patient is not pregnant.
  4. Zubrod performance status < 3.
  5. Life expectancy is not severely limited by concomitant illness.
  6. Serum creatinine < 2 mg/dL.
  7. Serum bilirubin < 2 times upper limit of normal (2 mg/dL).
  8. Alanine aminotransferase (SGPT) < 2 times upper limit of normal (112 IU/L).
  9. Participant has completed the informed consent process, understands the investigational nature of the study, agrees to participate, and has signed the informed consent.

Exclusion Criteria:

  1. Evidence of chronic active hepatitis or cirrhosis, and > 1 month from prior episode of hepatitis.
  2. Presence of an active infection.
  3. HIV positive.
  4. Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
  5. Recent history of parasite infection.
  6. Recent history of allergic reaction.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483067

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michael Andreeff, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00483067     History of Changes
Other Study ID Numbers: DM97-232
Study First Received: June 5, 2007
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Idiopathic Hypereosinophilic Syndrome
Leukemia
2-Chlorodeoxyadenosine
Cladribine
Cytarabine
Ara-C
2-CdA
G-CSF
HES

Additional relevant MeSH terms:
Leukemia
Syndrome
Hypereosinophilic Syndrome
Neoplasms by Histologic Type
Neoplasms
Disease
Pathologic Processes
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Cladribine
Cytarabine
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014