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Home > "F" Clinical Trials Conditions > FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia  FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
For Condition: unspecified childhood solid tumor, protocol specific,relapsing chronic myelogenous leukemia,childhood chronic myelogenous leukemia,recurrent childhood acute lymphoblastic leukemia,refractory chronic lymphocytic leukemia,recurrent childhood acute myeloid leukemia
Status: Recruiting
Sponsor(s): Children's Oncology Group , 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 I trial to study the effectiveness of FR901228 in treating children who have refractory or recurrentsolid tumors or leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of FR901228 in pediatric patients with refractory or recurrent solid tumors. - Determine the dose-limiting toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Assess tolerability of this drug at the solid tumor MTD in patients with refractory or recurrent leukemia. - Determine, preliminarily, the antitumor activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients with solid tumors receive escalating doses of FR901228 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. Cohorts of 3 patients (6 patients total) with leukemia receive FR901228 as above at the MTD. Patients are followed for survival. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignancy - Extracranial solid tumors or brain tumors* - Diagnosis of leukemia allowed after maximum tolerated dose is determined NOTE: *Histology requirement waived for patients with brain stem or optic pathway tumors - Disease must be refractory to conventional therapy or no effective conventional therapy exists - CNS tumors resulting in neurological deficits must be stable for 2 weeks before study entry PATIENT CHARACTERISTICS: Age - Under 22 Performance status - Karnofsky 60-100% (over 10 years old) - Lansky 60-100% (10 years old and under ) Life expectancy - At least 8 weeks Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (RBC transfusions allowed) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 5 times ULN - Albumin at least 2 g/dL Renal - Creatinine normal OR - Glomerular filtration rate at least 70 mL/min - Calcium normal (with or without supplementation) Cardiovascular - Shortening fraction at least 27% by echocardiogram OR ejection fraction at least 50% by MUGA - No symptomatic congestive heart failure - No uncontrolled cardiac arrhythmia - QTc less than 450 msec Pulmonary - No evidence of dyspnea at rest - No exercise intolerance - Pulse oximetry greater than 94% Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Magnesium and potassium normal (with or without supplementation) - No uncontrolled seizure disorder - No uncontrolled infection - No graft-vs-host disease - No seizure disorder unless well controlled and not on enzyme-inducing anticonvulsants PRIOR CONCURRENT THERAPY: Biologic therapy - At least 1 week since prior growth factors - At least 3 weeks since prior biologic therapy or immunotherapy and recovered - At least 6 months since prior allogeneic stem cell transplantation - No concurrent routine prophylactic growth factors Chemotherapy - At least 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered - No prior FR901228 - No other concurrent anticancer chemotherapy Endocrine therapy - Concurrent dexamethasone for CNS tumors allowed if on stable dose or decreasing dose for at least 1 week before study entry Radiotherapy - Recovered from prior radiotherapy - At least 2 weeks since prior local palliative radiotherapy (small port) - At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least 50% of pelvis - At least 6 weeks since other prior substantial bone marrow radiation Surgery - Not specified Other - No concurrent enzyme-inducing anticonvulsants - No concurrent medications associated with prolongation of QTc interval - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaryamFouladi, Study Chair, St. Jude Children's Research Hospital
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-2899
United States
Recruiting Robert Wells 513-636-4200
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Gary Houten Dahl 650-497-8238
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Mitchell Cairo 212-305-8316
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting H. Nicholson 503-494-1543
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Ronald Dubowy 315-464-5294
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Regina Jakacki 412-692-5055
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting James Croop 317-278-4822
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2916
United States
Recruiting Anne Angiolillo 202-884-2800
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Adamson 215-590-5448
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting John Holcenberg 206-987-2106
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Mark Bernstein 514-345-4969
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Sylvain Baruchel 416-813-7795
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Brenda Weigel 612-626-8484
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-4822
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
Additional Information:
Study ID Numbers: CDR0000269671; COG-ADVL0212,NCI-03-C-0307
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053963
Other Childhood Chronic Myelogenous Leukemia Studies:
1. Homoharringtonine in Treating Patients With Chronic Myelogenous Leukemia
2. PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome
3. FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
4. Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia
5. Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
Related Studies:
Other childhood chronic myelogenous leukemia Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
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