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Gemtuzumab in Treating Patients With Myelodysplastic Syndrome Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Gemtuzumab in Treating Patients With Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gemtuzumab in Treating Patients With Myelodysplastic Syndrome Clinical research trials and Gemtuzumab in Treating Patients With Myelodysplastic Syndrome health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Gemtuzumab in Treating Patients With Myelodysplastic Syndrome. Gemtuzumab in Treating Patients With Myelodysplastic Syndrome Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Gemtuzumab in Treating Patients With Myelodysplastic Syndrome clinical trial. Human subjects often get the best healthcare possible for their Gemtuzumab in Treating Patients With Myelodysplastic Syndrome condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gemtuzumab in Treating Patients With Myelodysplastic Syndrome  Gemtuzumab in Treating Patients With Myelodysplastic Syndrome
Gemtuzumab in Treating Patients With Myelodysplastic Syndrome
For Condition: Refractory Anemia,de novo myelodysplastic syndromes,refractory anemia with excess blasts,refractory anemia with excess blasts in transformation,refractory anemia with ringed sideroblasts
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Monoclonal antibodies such as gemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Randomized phase II trial to study the effectiveness of gemtuzumab in treating patients who have myelodysplastic syndrome.
Details: OBJECTIVES: I. Determine the total survival of patients with intermediate-2 or high-risk myelodysplastic syndrome treated with gemtuzumab ozogamicin. II. Assess the quality of life of patients treated with this drug. III. Compare two different dose schedules of this drug in these patients. IV. Determine the safety of this drug in these patients. V. Determine the number of patients treated with this drug that achieve complete remission, partial remission, stable disease, major and minor hematologic improvements, or major and minor cytogenetic responses. VI. Determine the progression-free survival, relapse-free survival, and time to progression to acute myeloid leukemia in patients treated with this drug. VII. Determine the number of transfusions, number of days on IV antibiotics, and the number of days hospitalized in patients treated with this drug. VIII. Determine the possible predictors of response in patients treated with this drug, including age, karyotype, and multi-drug resistance efflux. IX. Determine the pharmacokinetics of this drug in these patients. X. Correlate the results of pharmacogenomic studies to gene activation and response to therapy in patients treated with this drug. PROTOCOL OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (60 and under vs over 60) and IPSS score (1.5-2.0 vs 2.5 and greater). Patients are randomized to one of two treatment arms. Arm I: Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Arm II: Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. After completion of induction therapy, patients in both arms with stable or responding disease may receive post-remission therapy comprising up to 3 additional doses of gemtuzumab ozogamicin approximately 28-42 days apart. Quality of life is assessed at baseline, on day 29 for arm I, on day 43 for arm II, on day 127 for patients that receive additional doses of study drug, and at 8 months for all patients. Patients who do not respond to induction therapy are followed monthly for 8 months and then every 3 months thereafter. Patients who receive post-remission therapy are followed every 3 months. PROJECTED ACCRUAL: Approximately 128 patients (64 per treatment arm) will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed myelodysplastic syndrome (MDS); Refractory anemia (RA); RA with ringed sideroblasts; RA with excessive blasts (RAEB); RAEB in transformation (stable disease for at least 2 months) - No chromosomal abnormalities including t(8;21), inv(16), or t(15;17) - No chronic myelomonocytic leukemia proliferative type (WBC greater than 12,000/mm3) - No known CNS involvement with MDS blast progression - International Prognostic Scoring System (IPSS) score at least 1.5 --Prior/Concurrent Therapy-- - Biologic therapy: No prior stem cell transplantation; No prior anti-CD33 antibodies; At least 4 weeks since prior hematopoietic growth factors, epoetin alfa, or cytokine therapy - Chemotherapy: No prior chemotherapy for MDS or other malignancy; No concurrent cytotoxic chemotherapy - Endocrine therapy: At least 4 weeks since prior systemic steroids except topical or inhaled steroids; No concurrent systemic steroids except topical or inhaled steroids - Radiotherapy: No prior radiotherapy for MDS or other malignancy - Surgery: No prior organ transplantation - Other: At least 4 weeks since prior immunosuppressive therapy; At least 4 weeks since prior investigational agents; No concurrent immunosuppressive therapy; No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin less than 1.5 mg/dL - Renal: Creatinine less than 2.0 mg/dL - Cardiovascular: No severe cardiac disease - Pulmonary: No severe pulmonary disease - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 1 year after study; HIV negative; No other prior active malignancy except basal cell or squamous cell skin cancer; No uncontrolled infections
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchiller, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000068805; NCI-G01-1996,UCLA-0012052,W-AR-0903B1-207-US
Study Start Date: February 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022321
Other De Novo Myelodysplastic Syndromes Studies:
1. Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes
2. Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
3. CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality
4. Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
5. Infliximab in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other de novo myelodysplastic syndromes Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Gemtuzumab in Treating Patients With Myelodysplastic Syndrome
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