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Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes Clinical research trials and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes. Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes clinical trial. Test subjects typically obtain the finest healthcare available for their Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes  Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
For Condition: atypical chronic myeloid leukemia,Chronic Myelomonocytic Leukemia,myelodysplastic and myeloproliferative disease,Myelodysplastic Syndromes
Status: Recruiting
Sponsor(s): Cell Therapeutics , National Cancer Institute (NCI)
Synopsis: 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 myelodysplastic syndromes.
Details: OBJECTIVES: - Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who achieve a major hematologic improvement after treatment with arsenic trioxide. - Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug. - Determine the durability of responses in patients treated with this drug. - Determine the duration of overall and progression-free survival of patients treated with this drug. - Assess the quality of life of patients treated with this drug. - Assess the toxicity profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to risk score (low risk vs high risk). Patients receive arsenic trioxide IV 5 days a week on weeks 1-2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better may receive additional courses of treatment. Patients who achieve a complete remission (CR) should receive 2 additional courses of treatment after documentation of CR. Quality of life is assessed at baseline, every 8 weeks during study, and then at 4 weeks after study completion. Patients are followed at 4 weeks, every 3 months until completion of study treatment, and then annually thereafter. PROJECTED ACCRUAL: A total of 30-110 patients (15-55 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of myelodysplastic syndromes (MDS) - Refractory anemia (RA) - RA with ringed sideroblasts - RA with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - Low-risk MDS patients: - If serum erythropoietin less than 200 IU/mL, must have failed prior recombinant epoetin alfa (EPO) trial - No prior acute myeloid leukemia PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - More than 3 months Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2.5 times upper limit of normal (ULN) - SGPT and SGOT no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - Absolute QT interval less than 460 msec in the presence of magnesium greater than 1.8 mg/dL and potassium greater than 4.0 mEq/L Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 30 days since prior biologic therapy (except recombinant EPO in low-risk MDS patients) Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - At least 30 days since prior radiotherapy Surgery: - Not specified Other: - At least 30 days since prior cytotoxic agents - At least 30 days since prior investigational agents - No prior arsenic trioxide
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottStromatt, Study Chair, Cell Therapeutics
Green Cancer Center at Scripps Clinic *Recruiting*
La Jolla, California, 92037-1027
United States
Recruiting James Mason 858-554-8597
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033-0804
United States
Recruiting Dan Douer 323-865-3145
Corpus Christi Cancer Center *Recruiting*
Corpus Christi, Texas, 78412
United States
Recruiting Michael Nash 361-993-3456
Lynn Regional Cancer Center West *Recruiting*
Boca Raton, Florida, 33428
United States
Recruiting Arnold Berliner 561-883-7600
Georgia Cancer Specialists - Northside Office *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Mansoor Saleh 404-256-4777
St. Joseph Hospital Regional Cancer Center - Orange *Recruiting*
Orange, California, 92868-3849
United States
Recruiting Leonard Sender 714-771-8921
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Gary Schiller 310-825-5513
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Alan List 520-626-2340
Additional Information:
Study ID Numbers: CDR0000068734; NCI-G01-1971,CTI-1058,UCLA-HSPC-010104701
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020969
Other Myelodysplastic And Myeloproliferative Disease Studies:
1. Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
2. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
3. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
4. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
5. PTK787/ZK 222584 in Treating Patients With Primary or Secondary Myelodysplastic Syndromes
Related Studies:
Other myelodysplastic and myeloproliferative disease Clinical Trials
Other Georgia Clinical Trials
Other Atlanta Clinical Trials
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
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