- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00016861
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
Pediatric Phase I and Pharmacokinetic Study of Irinotecan
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 Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030-2399
- Texas Children's Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Susan M. Blaney, MD, Texas Children's Cancer Center
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCCC-H-6957
- CDR0000068568 (Registry Identifier: PDQ (Physician Data Query))
- TCCC-GCRC-0654
- NCI-V01-1654
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unspecified Childhood Solid Tumor, Protocol Specific
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingCollection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid TumorsUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Kantonsspital GraubuendenUnknownUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificSwitzerland
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Vanderbilt UniversityNational Cancer Institute (NCI)TerminatedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
University of ChicagoNational Cancer Institute (NCI)CompletedSirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By SurgeryUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)WithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyWithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Hematopoietic/Lymphoid CancerUnited States
-
Children's Cancer and Leukaemia GroupUnknownUnspecified Childhood Solid Tumor, Protocol SpecificIreland, United Kingdom
Clinical Trials on irinotecan hydrochloride
-
H. Lee Moffitt Cancer Center and Research InstituteTerminatedGlioma | Astrocytoma | OligodendrogliomaUnited States
-
University of ArizonaNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
Japan Multinational Trial OrganizationCompleted
-
Luye Pharma Group Ltd.CompletedAdvanced Solid TumorChina
-
Mayo ClinicNational Comprehensive Cancer NetworkCompletedStage III Gallbladder Cancer AJCC v8 | Stage IIIA Gallbladder Cancer AJCC v8 | Stage IIIB Gallbladder Cancer AJCC v8 | Refractory Gallbladder Carcinoma | Stage IV Gallbladder Cancer AJCC v8 | Stage IV Distal Bile Duct Cancer AJCC v8 | Stage IV Intrahepatic Bile Duct Cancer AJCC v8 | Stage IVB Gallbladder... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma and other conditionsUnited States
-
Fudan UniversityNot yet recruitingSmall Cell Lung Cancer RecurrentChina
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedBreast CancerUnited States, Canada
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
New Approaches to Brain Tumor Therapy ConsortiumNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States