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DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Clinical research trials and DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas healthcare trials occur in a lot of 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 generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas. DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas clinical trial. Test subjects typically receive the most effective healthcare possible for their DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas  DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
For Condition: childhood Hodgkin's lymphoma,childhood brain tumor,childhood solid tumor,childhood non-Hodgkin's lymphoma
Status: Completed
Sponsor(s): Daiichi Pharmaceuticals ,
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 DX-8951f in treating children who have advanced solid tumors or lymphomas that have not responded to previous therapy.
Details: OBJECTIVES: - Determine the maximum tolerated dose of exatecan mesylate (DX-8951f) with and without filgrastim (G-CSF) in pediatric patients with advanced solid tumors or lymphomas. - Determine the toxic effects, including dose-limiting toxicity, of exatecan mesylate in these patients. - Determine the pharmacokinetics of exatecan mesylate in these patients. - Determine the recommended dose of exatecan mesylate for phase II study. - Determine the antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of exatecan mesylate (DX-8951f). Patients are stratified according to prior treatment (minimally treated vs heavily treated). Patients receive exatecan mesylate IV over 30 minutes daily for 5 days. Patients in dose levels 5 and above also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing for at least 7 days or until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of exatecan mesylate with and without G-CSF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 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 advanced solid tumors, including brain tumors and lymphomas, that have failed standard therapy (surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no standard therapy exists - Histology requirement waived for brain stem gliomas PATIENT CHARACTERISTICS: Age: - 21 and under at diagnosis Performance status: - ECOG 0-2 Life expectancy: - At least 8 weeks Hematopoietic: - Absolute neutrophil count at least 750/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 8.5 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases) Renal: - Creatinine no greater than 1.5 times ULN OR - GFR at least 70 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - No history of severe or life-threatening hypersensitivity to camptothecin analogs - HIV negative - No other concurrent severe or uncontrolled medical illness - No systemic infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Recovered from prior immunotherapy Chemotherapy: - See Disease Characteristics - Recovered from prior chemotherapy Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior extensive radiotherapy involving cranial, whole pelvic, or at least 25% of bone marrow reserve - Recovered from prior radiotherapy - Concurrent localized radiotherapy for pain allowed Surgery: - See Disease Characteristics - Recovered from prior surgery Other: - No other concurrent antitumor therapy - No concurrent drugs that induce or inhibit CYP3A enzyme
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
Children's Medical Center of Dallas
Dallas, Texas, 75235
United States
Institute for Drug Development
San Antonio, Texas, 78245-3217
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067330; DAIICHI-8951A-PRT013,MSKCC-99071,UTHSC-9895011445,NCI-V99-1573
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004212
Other Childhood Brain Tumor Studies:
1. Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
2. Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
3. Study of @neWorld: A Virtual Community for Children With Cancer
4. Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer
5. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
Related Studies:
Other childhood brain tumor Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
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