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Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes 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 Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes Clinical research trials and Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes 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 Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes. Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes 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 Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes clinical trial. Human subjects often get the best healthcare possible for their Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes 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 > "M" Clinical Trials Conditions > Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes  Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
For Condition: previously treated myelodysplastic syndromes,secondary acute myeloid leukemia,recurrent childhood acute myeloid leukemia
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractoryacute myeloid leukemia or myelodysplastic syndrome.
Details: OBJECTIVES: - Determine the safety and maximum tolerated dose of gemtuzumab ozogamicin in combination with conventional chemotherapy in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes. - Determine the efficacy of this regimen in these patients. - Correlate the likelihood of leukemic blast cells to undergo apoptosis in vitro with the efficacy of this regimen in these patients. - Correlate drug resistance as manifested by dye efflux or multiple drug resistance-1 expression by leukemic blast cells with the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study of gemtuzumab ozogamicin. Patients are assigned by cohort to 1 of 2 treatment regimens. - Regimen A: Patients receive cytarabine IV over 2 hours every 12 hours on days 1-4, mitoxantrone IV over 1 hour on days 3-6, and gemtuzumab ozogamicin IV over 2 hours on day 7. - Regimen B: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, asparaginase intramuscularly on days 2 and 9, and gemtuzumab ozogamicin IV over 2 hours on day 3. Cohorts of 3-6 patients receive de-escalating doses of gemtuzumab ozogamicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 6 months, every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of primary acute myeloid leukemia (AML) or myelodysplastic syndromes - Relapsed (remission duration less than 1 year) OR - Failed induction (failed to achieve an initial complete response) - Patients with AML as a second malignant neoplasm allowed provided no other prior therapy for AML - M2 or M3 bone marrow aspirate at time of study entry - No Fanconi's anemia - No known CNS leukemia PATIENT CHARACTERISTICS: Age: - 21 and under Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 1.5 times normal - AST or ALT less than 2.5 times upper limit of normal - No history of veno-occlusive disease of the liver defined as weight increase of more than 5% over baseline and serum bilirubin greater than 5 mg/dL within 20 days after receipt of chemotherapy Renal: - Creatinine no greater than 1.5 times normal OR - Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR - Equivalent GFR by institutional normal range Cardiovascular: - Shortening fraction more than 27% by echocardiogram or normal for institution OR - Ejection fraction more than 50% by MUGA Other: - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 180 days since prior hematopoietic stem cell transplantation Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardAplenc, Study Chair, Children's Hospital of Philadelphia
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Susan Cohn 773-880-4562
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Arthur Ritchey 412-692-5949
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Children's Hospital of Michigan *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Yaddanapudi Ravindranath 313-745-5649
Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Michael Harris 201-996-5437
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Neyssa Marina 650-723-5535
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting John Perentesis 513-636-6090
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Cindy Schwartz 410-955-2457
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6838
United States
Recruiting James Whitlock 615-936-1762
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Stephen Lauer 404-250-2781
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0296
United States
Recruiting Stephen Hunger 352-392-5633
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook, New York, 11794
United States
Recruiting Robert Parker 631-689-6000
Cardinal Glennon Children's Hospital *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting Dennis O'Connor 314-577-5638
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Albert Moghrabi 514-345-4969
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Victor Blanchette 416-598-5852
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Nita Seibel 202-884-2144
Midwest Children's Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Bruce Camitta 414-456-4118
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425-0721
United States
Recruiting Julio Barredo 803-792-2957
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Joann Ater 713-792-6665
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Beverly Lange 215-590-2249
Children's Mercy Hospital *Recruiting*
Kansas City, Missouri, 64108
United States
Recruiting Maxine Hetherington 816-234-3265
McGill University Health Center - Montreal Children's Hospital *Recruiting*
Montreal, Quebec, H3G 1A4
Canada
Recruiting Carolyn Freeman 514-412-8040
Cook Children's Medical Center - Fort Worth *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting Timothy Griffin 682-885-4020
Children's Hospital of Columbus *Recruiting*
Columbus, Ohio, 43205-2696
United States
Recruiting Amanda Termuhlen 614-722-3552
Children's Hospital of Orange County *Recruiting*
Orange, California, 92868
United States
Recruiting Wei-Ping Shen 714-532-8636
Floating Hospital for Children *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Cynthia Kretschmar 617-636-5535
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Peter Steinherz 212-639-7951
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Robert Fallon 317-274-8784
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Philip Breitfeld 919-684-3377
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Douglas Hawkins 206-987-3096
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78207
United States
Recruiting Paul Thomas 210-704-3405
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6164
United States
Recruiting Diane Puccetti 608-263-0320
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting David Becton 501-320-5650
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Stephen Feig 310-825-5268
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-4822
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting C. Steuber 713-770-4200
Royal Children's Hospital *Recruiting*
Parkville, Victoria, 3052
Australia
Recruiting David Ashley 61-39-345-5522
Princess Margaret Hospital for Children *Recruiting*
Perth, Western Australia, 6001
Australia
Recruiting David Baker 61-8-9340-8234
Additional Information:
Study ID Numbers: CDR0000069145; COG-AAML00P2
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028899
Other Secondary Acute Myeloid Leukemia Studies:
1. PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome
2. Thalidomide in Treating Patients With Myelodysplastic Syndrome
3. Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
4. Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
5. Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
Related Studies:
Other secondary acute myeloid leukemia Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
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