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Home > "I" Clinical Trials Conditions > Iressa to Treat Solid Tumors in Children  Iressa to Treat Solid Tumors in Children
Iressa to Treat Solid Tumors in Children
For Condition: Tumors
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine 1) the highest dose of the experimental drug Iressa that can safely be given to children and adolescents with cancer, 2) the side effects of the drug in these patients, and 3) how the child's body handles (metabolizes) the drug over time. Iressa binds to epidermal growth factor receptor (EGFR) proteins. These proteins are found on the surface of some cancer cells and some normal cells and may help tumor cells grow and spread to other parts of the body. Iressa may block the effects of these growth factors as well as the growth of new blood vessels that nourish tumors. Patients under 22 years of age with a solid tumor cancer for whom no satisfactory standard therapy is available may be eligible for this study. Participants will have the following tests and procedures: - Iressa treatment: Patients will take one Iressa tablet daily in 28-day cycles. - Physical examinations: at least once weekly during the first 28-day cycle and periodically throughout the course of treatment. - Eye examinations: twice during the first treatment cycle and periodically throughout the course of treatment. - Blood tests: weekly during the first treatment cycle and periodically throughout the course of treatment. In addition, special blood tests will be done: before beginning treatment and on days 10 and 28 of the first treatment cycle to examine the effect of Iressa on VEGF, MMP-2, and MMP-9 - proteins in the blood that may reflect tumor growth and spread and formation of new tumor blood vessels; before beginning treatment to study the genes that control drug metabolism. - X-rays, CT scans, MRI scans: periodically throughout the course of treatment. - Pharmacology test: on days 10, 21 and 28 of the first course of treatment and day 28 of subsequent cycles. On day 10 of treatment cycle 1, eight blood samples of 1 teaspoon each will be drawn over 24 hours to measure blood levels of the drug. On the other test days, only one blood sample will be drawn. If possible, the blood will be collected through the child's permanent intravenous catheter (Hickman line or port-a-cath) or a heparin lock to avoid multiple needle sticks. - Buccal swab: before starting Iressa and on day 28 of the first treatment cycle. Cells are scraped from the inside of the cheek to examine the effect of Iressa on normal cells. - Test for the presence of EGFR receptor proteins on the surface of cancer cells. This test will be done on tissue samples that were stored after a prior surgery or biopsy, if available. Patients may continue to receive Iressa unless their tumor continues to grow during treatment, they develop unacceptable side effects, or other reason determined by the study doctor.
Details: ZD1839, a low molecular weight synthetic molecule, is a potent and selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. The phosphorylation action of this receptor is a major component of growth factor-induced mitogenic proliferation of cells. ZD1839 has been shown to have good antitumor activity in a wide range of human tumor xenografts following oral administration. Initial clinical data suggest that ZD1839 has good oral bioavailability and a long terminal half-life (range, 24 to 85 hours) in adults. In adult Phase I studies, ZD1839 has been shown to have promising clinical efficacy and to be well tolerated with either intermittent or daily dosing. Toxicities in adults included transient grade 1 or 2 diarrhea, acne like rash, nausea, vomiting, and elevations in serum transaminases; dose-limiting toxicity was diarrhea at a dose of 1,000 mg daily. Although limited data on pediatric malignancies are available, EGFR expression has been observed in neuroblastoma, rhabdomyosarcoma and high-grade gliomas. Upon exposure to ZD1839, a modest inhibition of growth was observed in all three pediatric tumor xenografts. In this study, we will determine the maximum tolerated dose and dose-limiting toxicity of ZD1839 administered orally once daily, and evaluate the pharmacokinetics of ZD1839 in children with recurrent or refractory solid tumors. As ZD1839 inhibits an enzyme and thus is not a dose responsive agent, the two doses being evaluated and compared in adult Phase II and III trials are significantly below the dose at which dose-limiting toxicity occurred. The lower dose of 250 mg is that at which significant anti-tumor activity first occurred and the higher dose of 500 mg is that which allowed uninterrupted daily drug delivery. In this trial, assuming that the surface area of an adult is 1.73m(2), the starting dosage will be 150 mg/m(2), which is approximately equivalent to the adult absolute dose of 250 mg; the second dose will be 300 mg/m(2), which is approximately equivalent to the adult absolute dose of 500 mg. Subsequent dose escalations will be in 100 mg/m(2) increments. Courses will be 28 days in duration and there will be no breaks between courses. In the absence of disease progression, treatment on this study may continue. Intra-patient dose escalation is not allowed; two dose de-escalations per patient will be allowed. During course 1 in all patients serial plasma samples for pharmacokinetic studies will be collected on Day 10, and then pre-dose samples will be collected once weekly for the next two weeks, then once monthly. In addition, during course 1, exploratory studies will be performed to evaluate the biological effects of ZD1839 on epithelial cells obtained from buccal smears and to evaluate the effects of ZD1839 on circulating levels of vascular endothelial growth factor (VEGF) and matrix metalloproteinases MMP-2 and MMP-9.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Age: Patients must be less than 22 years of age at the time of study entry. Histologic Diagnosis: Patients must have had histologic verification of solid tumor malignancy at original diagnosis. Patient's disease must be considered refractory to conventional therapy or for which no conventional therapy exists. Performance Status: Karnofsky greater than or equal to 50% for patients greater than 10 years of age and Lansky Play-Performance Scale greater than or equal to 50 for children less than or equal to 10 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score. Life Expectancy: Must be greater than or equal to 8 weeks. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. a. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea). b. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. c. XRT: Greater than or equal to 2 wks for local palliative XRT (small port); greater than or equal to 6 months must have elapsed if prior craniospinal XRT or if greater than or equal to 50% radiation of pelvis; greater than or equal to 6 wks must have elapsed if other substantial BM radiation. d. Stem Cell Transplant (SCT): No evidence of active graft vs. host disease. For allogeneic SCT, greater than or equal to 6 months must have elapsed. Growth factor(s): Must not have received within 1 week of entry onto this study. Study Specific: Patients on enzyme activating anticonvulsants will not be allowed on this study. ZD1839 should not be administered with drugs with known corneal toxicity (e.g., tamoxifen, chlorpromazine, amiodarone, chloroquine). Adequate Bone Marrow Function Defined As: For patients with solid tumors including status post Stem Cell Transplant (SCT): - Peripheral absolute neutrophil count (ANC) greater than or equal to 1000/microL. - Platelet count greater than or equal to 50,000/miciroL (transfusion independent) - Hemoglobin greater than or equal to 8.0 gm/dL (may receive RBC transfusions). Patients with solid tumors metastatic to bone marrow who have granulocytopenia, anemia, and/or thrombocytopenia are eligible provided they meet criteria, but will not be evaluable for hematological toxicity. Adequate Renal Function Defined As: An age-adjusted normal serum creatinine (see below) or a GFR greater than or equal to 70 ml/min/1.73m(2). Age less than or equal to 5 years, Maximum Serum Creatine (mg/dL) 0.8. Age greater than or equal to 5 and less than or equal to 10 years, Maximum Serum Creatinine (mg/dL) 1.0. Age greater than 10 and less than or equal to 15 years, Maximum Serum Creatinine (mg/dL) 1.2. Age greater than 15 years, Maximum Serum Creatinine (mg/dL) 1.5. Adequate Liver Function Defined As: - Total bilirubin less than or equal to 1.5 x institutional upper limit of normal for age, and - SGPT (ALT) less than or equal to 3 x institutional upper limit of normal for age and albumin greater than or equal to 2 g/dL. EXCLUSION CRITERIA: Pregnancy or Breast-Feeding: No information is available regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Patients who have an uncontrolled infection. Patients on enzyme activating anticonvulsants will not be allowed on this study. Patients with primary central nervous system tumors or known metastases to the central nervous system.
Total Enrollment: 45
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030062; 03-C-0062
Study Start Date: December 17, 2002
Record last reviewed: November 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050739
Other Tumors Studies:
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2. Phase I Trial of G3139 Plus Chemotherapy to Treat Relapsed Childhood Tumors
3. Iressa to Treat Solid Tumors in Children
4. Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients with Advanced Cancer
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Iressa to Treat Solid Tumors in Children
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