Clinical trial · Interventional
Gemcitabine in Treating Children With Refractory Solid Tumors
A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS
NCT00005577CI-TRIAL-00009314completedPhase 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)
Phase I trial to study the effectiveness of gemcitabine in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive gemcitabine IV over 30 minutes weekly for 2 weeks. Patients achieving objective response or stable disease after 3 weeks may receive additional courses of therapy every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) 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.
- interventionNames
- Drug: gemcitabine hydrochloride
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant solid tumor Confirmation made at original diagnosis * No bone marrow involvement * Refractory to conventional therapy and other therapies of higher priority according to CCG Phase I/II Priority List PATIENT CHARACTERISTICS: * Age: 1 to 21 * Performance status: 0-2 * Life expectancy: At least 2 months * Absolute neutrophil count at least 1,000/mm3 * Platelet count at least 100,000/mm3 (transfusion independent) * Hemoglobin at least 10 g/dL (transfusions allowed) * Bilirubin no greater than 1.5 times normal * AST less than 2.5 times normal * Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope GFR at least 70 mL/min * No seizure disorder Not pregnant or nursing * Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior cytokine therapy and recovered * No prior bone marrow transplantation * No more than 3 prior combination or single agent chemotherapy regimens * At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered
References
Publications (0)
Data not yet available
No reference posted for this study.