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Irinotecan in Treating Children With Refractory or Progressive Solid Tumors Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Irinotecan in Treating Children With Refractory or Progressive Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irinotecan in Treating Children With Refractory or Progressive Solid Tumors Clinical research trials and Irinotecan in Treating Children With Refractory or Progressive Solid Tumors health trials happen in many 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 measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Irinotecan in Treating Children With Refractory or Progressive Solid Tumors. Irinotecan in Treating Children With Refractory or Progressive Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Irinotecan in Treating Children With Refractory or Progressive Solid Tumors clinical trial. Human subjects often get the best healthcare available for their Irinotecan in Treating Children With Refractory or Progressive Solid Tumors condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Irinotecan in Treating Children With Refractory or Progressive Solid Tumors  Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Texas Children's Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children who have refractory or progressivesolid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan in children with refractory or progressive solid tumors. - Determine the pharmacokinetics of this drug and its metabolites (SN-38, SN-38G, and APC) administered with and without concurrent anticonvulsants in this patient population. - Determine the benefit this drug offers this patient population. OUTLINE: This is a dose-escalation, multicenter study. Patients are accrued into stratum 1 initially and into stratum 2 if stratum 1 closes due to dose-limiting toxicity of myelosuppression or diarrhea. Patients on anticonvulsants will be accrued into stratum 3 and must meet the eligibility criteria for the stratum that is open (stratum 1 or stratum 2). (Stratum 1 closed as of 2002-09-15). Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) with and without anticonvulsants 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. Patients are followed every 6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: Approximately 20-25 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor refractory to standard therapy or for which no known effective therapy exists - Brain tumors eligible - Histologic verification waived for brain stem gliomas - Evaluable disease - No bone marrow involvement PATIENT CHARACTERISTICS: Age: - 1 to 21 Performance status: - Karnofsky 50-100% (over age 10) - Lansky 50-100% (age 10 and under) Life expectancy: - At least 8 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic: - Bilirubin less than 1.5 mg/dL - SGPT less than 5 times normal Renal: - Creatinine normal OR - Glomerular filtration rate at least 70 mL/min Other: - No uncontrolled infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 6 months since prior autologous bone marrow transplantation (BMT) (not including stem cell rescue after high-dose chemotherapy) - At least 1 week since prior growth factors - No prior BMT with total body irradiation (stratum I) - No prior BMT with or without total body irradiation (stratum 2) - No prior allogeneic BMT (all strata) - No concurrent sargramostim (GM-CSF) - No other concurrent prophylactic growth factor support during the first course of therapy Chemotherapy: - At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) - No prior irinotecan - No more than 2 prior multi-agent chemotherapy regimens (stratum 2) - No other concurrent chemotherapy Endocrine therapy: - Concurrent dexamethasone allowed if on stable or decreasing dose for at least 2 weeks prior to study Radiotherapy: - At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis - At least 6 weeks since other prior substantial bone marrow radiotherapy - No prior central axis radiotherapy, pelvic radiotherapy, and/or total abdominal radiotherapy (stratum 2) Surgery: - Not specified Other: - Recovered from all prior therapy - No other concurrent investigational agents - Concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine) allowed if on stable dose for at least 2 weeks prior to study (stratum 3) - Concurrent valproic acid allowed if combined with another enzyme inducing anticonvulsant drug (stratum 3)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanBlaney, Study Chair, Texas Children's Cancer Center
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Additional Information:
Study ID Numbers: CDR0000068568; TCCC-GCRC-0654,NCI-V01-1654,TCCC-H-6957
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016861
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. FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
3. Gefitinib in Treating Children With Refractory Solid Tumors
4. Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
5. Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
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