Expired Study
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Houston, Texas 77030


Purpose:

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 progressive solid tumors.


Study summary:

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.


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)


NCT ID:

NCT00016861


Primary Contact:

Study Chair
Susan M. Blaney, MD
Texas Children's Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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