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

This study has been terminated.
(Sponsor terminated trial)
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Veeda Oncology
ClinicalTrials.gov Identifier:
NCT00251511
First received: November 8, 2005
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Myelodysplastic Syndrome
Drug: Arsenic Trioxide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Veeda Oncology:

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

Enrollment: 60
Study Start Date: August 2004
Study Completion Date: May 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00251511

Locations
United States, Texas
Veeda Oncology
Houston, Texas, United States, 77042
Sponsors and Collaborators
Veeda Oncology
Cephalon
Investigators
Principal Investigator: Ralph Boccia, MD Veeda Oncology
  More Information

No publications provided

Responsible Party: Veeda Oncology
ClinicalTrials.gov Identifier: NCT00251511     History of Changes
Other Study ID Numbers: I-04-001
Study First Received: November 8, 2005
Last Updated: May 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Disease
Pathologic Processes
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014