A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251511
Recruitment Status : Terminated (Sponsor terminated trial)
First Posted : November 10, 2005
Last Update Posted : May 11, 2012
Information provided by (Responsible Party):
Veeda Oncology

Brief Summary:

This is a Phase II, open-label, non-randomized study in patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS).

Each cycle of treatment will be 6 weeks in length. Patients will be evaluated every 6 weeks for response. Patients will be treated for a minimum of 12 weeks even in the absence of response. Following 12 weeks of treatment, patients will continue to receive study treatment until disease progression or unacceptable toxicity.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Arsenic Trioxide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome
Study Start Date : August 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Primary Study Endpoint:
  2. Determine the response rate (by IWG criteria) of patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS) to biweekly Trisenox plus daily Thalomid

Secondary Outcome Measures :
  1. Secondary Study Endpoint(s):
  2. Determine the toxicities associated with a biweekly Trisenox plus daily Thalomid regimen, the event-free survival, and the overall survival.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • To be eligible for the study, patients must fulfill all of the following criteria:

    1. Patients must have signed an IRB-approved informed consent.
    2. Patients with low, intermediate-1, intermediate-2, and high-risk MDS (defined by IPSS) with documented diagnosis of MDS (refractory anemia, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia with mixed lineage dysplasia, or chronic myelomonocytic leukemia).
    3. Patients must have a documented history of all transfusions (pRBC and/or platelets) received in the 60-day period prior to their initial Trisenox treatment on this protocol.
    4. Patients with ECOG Performance Status of 0 or 1 (see Appendix I).
    5. Absolute QT interval below 460 msec in the presence of serum potassium and magnesium values within the normal range.
    6. Patients must be >/= 18 years of age.
    7. Patients must either be not of child bearing potential or have a negative serum pregnancy test within 24 hours prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 24 months.
    8. For patients of childbearing potential, patient has agreed to use 2 reliable forms of contraception simultaneously for at least 1 month before beginning Thalomid therapy, during Thalomid therapy, and for 1 month following discontinuation of Thalomid therapy.
    9. Renal function: creatinine < 1.5 x institutional upper limit of normal (ULN), CTCAE Grade 1.
    10. Hepatic function: bilirubin </= 1.5 x ULN, CTCAE Grade 1. AST </= 2.5 x ULN, CTCAE Grade 1.
    11. Serum potassium >4.0mEq/dL and serum magnesium >1.8 mg/dL.

Exclusion Criteria:

  • Any of the following criteria will make the patient ineligible to participate in this study:

    1. Patients who have received prior chemotherapy or prior therapy with either Trisenox or Thalomid.
    2. Patients who have a history of hypersensitivity to arsenic or thalidomide or any of the components in these drugs.
    3. Patients with a significant history of cardiac disease (i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction in the last 6 months).
    4. Patients with a history of torsade de pointes.
    5. Patients planning to receive any concurrent therapy to treat MDS during the study treatment period.
    6. Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
    7. Patients with a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of these study drugs for MDS.
    8. Any patient who is pregnant or lactating.
    9. Any patient who is unable to comply with requirements of study.
    10. Patients with peripheral neuropathy >grade 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251511

United States, Texas
Veeda Oncology
Houston, Texas, United States, 77042
Sponsors and Collaborators
Veeda Oncology
Principal Investigator: Ralph Boccia, MD Veeda Oncology

Responsible Party: Veeda Oncology Identifier: NCT00251511     History of Changes
Other Study ID Numbers: I-04-001
First Posted: November 10, 2005    Key Record Dates
Last Update Posted: May 11, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Arsenic trioxide
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors