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Gefitinib in Treating Children With Refractory Solid Tumors Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Gefitinib in Treating Children With Refractory Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gefitinib in Treating Children With Refractory Solid Tumors Clinical research trials and Gefitinib in Treating Children With Refractory Solid Tumors healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Gefitinib in Treating Children With Refractory Solid Tumors. Gefitinib in Treating Children With Refractory Solid Tumors Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Gefitinib in Treating Children With Refractory Solid Tumors clinical trial. Human subjects often obtain the finest healthcare possible for their Gefitinib in Treating Children With Refractory Solid Tumors condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gefitinib in Treating Children With Refractory Solid Tumors  Gefitinib in Treating Children With Refractory Solid Tumors
Gefitinib in Treating Children With Refractory Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase I trial to study the effectiveness of gefitinib in treating children who have refractorysolid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of gefitinib in children with refractory solid tumors. - Determine the dose-limiting toxicity of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine, preliminarily, the antitumor activity of this drug in these patients. - Correlate the pharmacogenetic polymorphisms of this drug with pharmacokinetics and pharmacodynamics in these patients. OUTLINE: This is a dose-escalation, multicenter study. If myelosuppression is found to be the dose-limiting toxicity, patients are stratified according to prior therapy (more than 2 multiagent chemotherapy regimens or radiotherapy to more than 20% of the bone marrow or stem cell transplantation with or without total body irradiation vs more than 2 single-agent phase I or phase II agents) and extent of disease (bone marrow involvement vs meeting none of the stratum I criteria). Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib 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: Approximately 3-45 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor at original diagnosis - Refractory to conventional therapy and other therapies of higher priority according to the COG Phase I/II priority list or no conventional therapy exists - No primary CNS tumors or known metastases to the CNS PATIENT CHARACTERISTICS: Age: - Under 22 Performance status: - Karnofsky 50-100% (over 10 years of age) OR - Lansky 50-100% (10 years of age and under) Life expectancy: - At least 8 weeks Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 50,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 3 times ULN - Albumin at least 2 g/dL Renal: - Creatinine normal for age OR - Glomerular filtration rate at least 70 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 6 months since prior allogeneic stem cell transplantation (SCT) - No evidence of active graft-versus-host disease - At least 1 week since prior biologic agents - At least 1 week since prior hematopoietic growth factors - Recovered from prior immunotherapy Chemotherapy: - At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered Endocrine therapy: - No concurrent tamoxifen Radiotherapy: - At least 2 weeks since prior local palliative (small port) radiotherapy - At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis (6 weeks for radiotherapy to other substantial amount of bone marrow) - Recovered from prior radiotherapy Surgery: - Not specified Other: - No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, amiodarone, or chloroquine) - No concurrent enzyme-activating anticonvulsants - No concurrent proton pump inhibitors or H_2 blockers within 4 hours of gefitinib administration
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NajatDaw, Study Chair, St. Jude Children's Research Hospital
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Mark Bernstein 514-345-4969
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
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Mitchell Cairo 212-305-8316
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-2899
United States
Recruiting Robert Wells 513-636-4200
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Gary Houten Dahl 650-497-8238
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting James Croop 317-278-4822
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Regina Jakacki 412-692-5055
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Sylvain Baruchel 416-813-7795
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Brenda Weigel 612-626-8484
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 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
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-112
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000069406; NCI-03-C-0062,COG-ADVL0016
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040781
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
2. Fenretinide in Treating Children With Solid Tumors
3. Oxaliplatin in Treating Children With Advanced Solid Tumors
4. Gefitinib in Treating Children With Refractory Solid Tumors
5. Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Gefitinib in Treating Children With Refractory Solid Tumors
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