Clinical trial · Interventional
Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
NCT00024284CI-TRIAL-00009928completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 combining carboplatin and irinotecan in treating children who have refractory solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor, including primary brain tumor * Progressive disease on standard therapy or for which no standard therapy exists * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 1 to 21 Performance status: * Lansky 50-100% (age 10 and under) * Karnofsky 50-100% (over age 10) Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count greater than 1,000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * ALT no greater than 2.5 times upper limit of normal Renal: * Glomerular filtration rate at least 30 mL/min Other: * No active infection * No serious uncontrolled medical disorder * No psychiatric disorder or other disorder that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 6 months since prior allogeneic bone marrow transplantation without evidence of acute or chronic graft versus host disease * At least 3 months since prior autologous bone marrow or peripheral blood stem cell transplantation * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunotherapy Chemotherapy: * No more than 3 prior chemotherapy regimens * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No other concurrent chemotherapy Endocrine therapy: * Concurrent hormone replacement therapy or oral contraceptives allowed * No other concurrent hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy (including for brain metastases) and recovered * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent investigational anticancer drugs * No other concurrent antitumor therapy * No concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (Neurontin)
References
Publications (0)
Data not yet available
No reference posted for this study.