Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
Pediatric Phase I and Pharmacokinetic Study of Irinotecan
Verified date | November 2004 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | January 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 21 Years |
Eligibility |
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) |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Children's Cancer Center |
United States,
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