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Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia Clinical research trials and Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia. Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia clinical trial. Participants frequently get the best healthcare available for their Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia  Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
For Condition: childhood acute promyelocytic leukemia (M3),childhood chronic myelogenous leukemia,recurrent childhood acute myeloid leukemia,blastic phase chronic myelogenous leukemia,recurrent childhood acute lymphoblastic leukemia
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: Phase I trial to study the effectiveness of bortezomib in treating young patients who have refractory or recurrentleukemia.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose and recommended phase II dose of bortezomib in children with refractory or recurrent leukemia. - Determine the toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. Secondary - Determine, preliminarily, the antitumor activity of this drug in these patients. - Determine, preliminarily, the biologic activity of this drug in these patients. OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1.5-36 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed leukemia of 1 of the following types: - Acute lymphoblastic leukemia - Acute myeloid leukemia - Chronic myelogenous leukemia in blast crisis - Relapsed or refractory disease - Immunophenotypically confirmed disease, either at initial diagnosis or relapse - More than 25% blasts in the bone marrow (M3 bone marrow) - Active extramedullary disease (except leptomeningeal disease) allowed - No known curative therapy or therapy proven to prolong survival with an acceptable quality of life available PATIENT CHARACTERISTICS: Age - 1 to 21 Performance status - Karnofsky 50-100% (for patients age 11 to 21) OR - Lansky 50-100% (for patients age 10 and under) Life expectancy - Not specified Hematopoietic - Platelet count 20,000/mm^3* - Hemoglobin 8.0 g/dL* - WBC < 20,000/mm^3** (hydroxyurea for cytoreduction allowed) - No hyperleukocytosis (i.e., WBC > 100,000/mm^3) NOTE: *Transfusion allowed NOTE: **An exception may be made at the discretion of the investigator Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) - ALT 5 times ULN - Albumin 2 g/dL Renal - Creatinine clearance or radioisotope glomerular filtration rate 70 mL/min OR - Creatinine based on age as follows: - 0.8 mg/dL for patients age 5 and under - 1.0 mg/dL for patients age 6 to 10 - 1.2 mg/dL for patients age 11 to 15 - 1.5 mg/dL for patients age 16 to 21 Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy - Recovered from prior immunotherapy - At least 7 days since prior filgrastim (G-CSF) or sargramostim (GM-CSF) - At least 7 days since prior biologic agents - At least 3 months since prior stem cell transplantation or rescue and no evidence of active graft-versus-host disease - No concurrent prophylactic G-CSF during course 1 of study - No concurrent immunotherapy - No concurrent biologic therapy Chemotherapy - Recovered from prior chemotherapy - At least 24 hours since prior hydroxyurea for cytoreduction - At least 6 weeks since prior nitrosoureas - No concurrent chemotherapy Endocrine therapy - At least 7 days since prior steroids Radiotherapy - Recovered from prior radiotherapy - At least 2 weeks since prior small port local palliative radiotherapy - At least 3 months since prior total body irradiation, craniospinal irradiation, or irradiation to more than 50% of the pelvis - At least 6 weeks since other prior substantial bone marrow radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - At least 7 days since prior retinoids - No other concurrent investigational agents - No other concurrent anticancer agents - No concurrent anticonvulsant medications known to activate the cytochrome p450 system (e.g., phenytoin, carbamazepine, or phenobarbital) - Concurrent benzodiazepines and gabapentin are allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TerzahHorton, Study Chair, Texas Children's Cancer Center
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Beverly Lange 215-590-2249
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Victor Blanchette 416-598-5852
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-4822
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting John Perentesis 513-636-6090
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Albert Moghrabi 514-345-4969
Children's Hospital Medical Center of Akron *Recruiting*
Akron, Ohio, 44308
United States
Recruiting Jeffrey Hord 330-543-8580
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
State University of New York Health Science Center at Brooklyn College of Medicine *Recruiting*
Brooklyn, New York, 11203
United States
Recruiting Sreedhar Rao 718-270-1693
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Douglas Hawkins 206-987-3096
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting James Croop 317-278-4822
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Arthur Ritchey 412-692-5949
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Nita Seibel 202-884-2144
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Linda Granowetter 212-305-8652
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Neyssa Marina 650-723-5535
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Doernbecher Children's Hospital at Oregon Health & Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting H. Nicholson 503-494-1543
Additional Information:
Study ID Numbers: CDR0000350340; COG-ADVL0317
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077467
Other Recurrent Childhood Acute Lymphoblastic Leukemia Studies:
1. Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
2. Chemotherapy, Biological Therapy, and/or Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
3. Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
4. STI571 in Treating Patients With Recurrent Leukemia
5. Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Allogeneic Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Related Studies:
Other recurrent childhood acute lymphoblastic leukemia Clinical Trials
Other California Clinical Trials
Other Palo Alto Clinical Trials
Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
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