Status:
COMPLETED
Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
University of Michigan
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them fr...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of arsenic trioxide and gemtuzumab ozogamicin to achieve complete and partial remissions in patients with advanced myelodysplastic syndromes. Secondary ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of one of the following hematologic malignancies:
- Myelodysplastic syndromes (MDS) of one of the following French-American-British (FAB) classifications:
- Refractory anemia with excess blasts (RAEB) (WHO RAEB-1)
- RAEB in transformation (RAEB-t) (RAEB-2)
- Chronic myelomonocytic leukemia (CMML) with \> 5% myeloblasts (WHO CMML-2)
- International Prognostic Scoring System (IPSS) score of intermediate-2 or higher in the setting of \> 5% myeloblasts
- Acute myeloid leukemia that has evolved from MDS
- Must not be a candidate for bone marrow transplantation as first-line therapy or must have declined bone marrow transplantation
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of at least 4 months
- Serum potassium ≥ 4.0 milliequivalent (mEq/dL) and serum magnesium ≥ 1.8 mg/dL (supplemental electrolytes allowed)
- Absolute corrected QT interval (QTc) interval \< 460 msec
- No serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the patient at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent
- Not pregnant or nursing
- Fertile patients must be willing to use adequate contraception (barrier method with spermicidal jelly, intrauterine device (IUD), or oral contraceptives)
- Negative pregnancy test
- Creatinine \> 2.5 mg/dL
- serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \> 1.5 times upper limit of normal
- Bilirubin \> 2.0 mg/dL
- No history of malignancy within the past 3 years other than MDS except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- Arsenic trioxide is contraindicated in patients who are hypersensitive to arsenic
- PRIOR CONCURRENT THERAPY:
- No prior bone marrow transplantation
- Must not receive another investigational or approved therapy for MDS within 4 weeks of study enrollment, including growth factors (within 1 week of study enrollment)
- No prior arsenic trioxide or gemtuzumab ozogamicin
- No other concurrent cytotoxic drugs or investigational agents
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00274781
Start Date
February 1 2004
End Date
November 1 2010
Last Update
July 10 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195