Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

NCT00118196 | Terminated Phase 2 DMC

• 3 other identifiers: CDR0000433313MUSC-MDS2773MUSC-15348
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving azacitidine together with arsenic trioxide works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; chronic myelomonocytic leukemia

Outcome Measures

Primary Outcomes (1)

• Response rate (overall and confirmed) as measured by International Working Group (IWG) standardized criteria for MDS at day 113 and then every 4 weeks until completion of study treatment

Secondary Outcomes (3)

• Time to treatment failure as assessed by the Kaplan-Meier method at completion of study treatment

• Progression-free survival as assessed by the Kaplan-Meier method at completion of study treatment

• Toxicity as assessed by the Kaplan-Meier method and NCI-CTCAE version 3.0 during treatment until 30 days after completion of study treatment

Interventions

arsenic trioxide DRUG

azacitidine DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of myelodysplastic syndrome or chronic myelomonocytic leukemia * International Prognostic Scoring System (IPSS) score ≥ intermediate-1 * Low IPSS score allowed provided patient meets ≥ 1 of the following criteria: * Platelet count ≤ 50,000/mm\^3 * Required platelet or packed red cell transfusions within the past 4 weeks * Neutropenic (i.e., absolute neutrophil count \< 1,000/mm\^3) AND has infections requiring antibiotic treatment * No prior leukemia or refractory anemia with excess blasts in transformation PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 12 weeks Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Baseline QTc \< 500 msec * QTc interval \< 460 msec with potassium \> 4.0 mEq/L and magnesium \> 1.8 mg/L Immunologic * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs * No ongoing or active infection * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No other malignancy within the past 12 months PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior administration of any of the following: * Interferon * Filgrastim (G-CSF), sargramostim (GM-CSF), epoetin alfa, or other hematopoietic cytokines * Thalidomide or thalidomide analogs * No concurrent epoetin alfa Chemotherapy * More than 4 weeks since prior chemotherapy * No prior arsenic trioxide or azacitidine * No other concurrent chemotherapy Endocrine therapy * More than 4 weeks since prior steroids * No concurrent androgenic steroids * Concurrent steroids for adrenal failure or as prophylaxis for nausea allowed Radiotherapy * Not specified Surgery * Not specified Other * More than 4 weeks since prior retinoids * No other concurrent investigational agents * No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Interventions

Arsenic Trioxide; Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Robert K. Stuart, MD

  Medical University of South Carolina

  STUDY CHAIR

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: July 8, 2005
• First Posted: July 11, 2005
• Study Start: April 1, 2005
• Primary Completion: August 11, 2006
• Study Completion: August 11, 2006
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)