Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Leukemia, Chronic Myeloide Leukemia, Myelodysplasia, Lymphoma, or Myeloma
Recruitment status was Active, not recruiting
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||July 23, 2008|
|Start Date ICMJE||November 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003885 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Leukemia, Chronic Myeloide Leukemia, Myelodysplasia, Lymphoma, or Myeloma|
|Official Title ICMJE||Phase II Study of Arsenic Trioxide in Relapsed/Refractory Acute Leukemia and Blast Crisis of Chronic Myeloid Leukemia|
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute leukemia, chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma.
OBJECTIVES: I. Determine the effect of arsenic trioxide on the remission rate in patients with recurrent or refractory acute leukemia, blast crisis chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma. II. Determine the time to progression and survival in patients treated with this regimen. III. Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients are stratified into 1 of 8 categories: first relapse no greater than 6 months after complete response vs second relapse or refractory vs prior hematologic disorder vs myeloid blast crisis of chronic myeloid leukemia vs lymphoid leukemia vs lymphoma vs myeloma vs myelodysplasia. Patients receive IV arsenic trioxide over 2-3 hours for 5 consecutive days with 2 days of rest. Treatment continues in the absence of disease progression until complete response or 90 days is reached. Upon achieving complete response, treatment is discontinued for 30 days. Patients exhibiting complete response receive a second 28 day course of consolidation therapy while in remission starting no sooner than 31 days after the end of induction therapy. Patients are followed monthly.
PROJECTED ACCRUAL: A total of 14-29 patients per lymphoma and myeloma stratum and a total of 31 patients per leukemia stratum will be accrued for this study within 18-24 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: arsenic trioxide|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||60|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory acute leukemia (myeloid or lymphoid), blast crisis chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma of all FAB subtypes
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL (except for leukemic infiltration dysfunction) Alkaline phosphatase less than 2 times upper limit of normal (except for leukemic infiltration dysfunction) Renal: Creatinine no greater than 2.0 mg/dL Other: No active infection Not pregnant Fertile patients must use effective contraception No history of seizure disorders
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 weeks since prior chemotherapy (except hydroxyurea) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents Concurrent antibiotic therapy allowed for stable patients
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00003885|
|Other Study ID Numbers ICMJE||CDR0000067053, OLMMC-9808, OLMMC-FDR001699, NCI-V99-1545|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Our Lady of Mercy Medical Center Comprehensive Cancer Center|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||June 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP