Clinical trial · Interventional
Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
NCT00006095CI-TRIAL-00013822completedPhase 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of vincristine plus irinotecan in treating children who have solid tumors that have not responded to previous therapy.
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 |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan
- interventionNames
- Drug: irinotecan hydrochloride
- Drug: vincristine sulfate
- type
- EXPERIMENTAL
- label
- Vincristine sulfate 2.0 mg/m2/wk and Irinotecan
- interventionNames
- Drug: irinotecan hydrochloride
- Drug: vincristine sulfate
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Length of study
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed initial diagnosis of malignant solid tumor refractory to conventional therapy or for which no effective therapy exists * Brain tumors allowed if not on anticonvulsants * Brainstem gliomas allowed without histologic diagnosis * Solid lymphomas allowed * No bone marrow involvement PATIENT CHARACTERISTICS: Age: * 1 to 21 Performance status: * Karnofsky 50-100% if over 10 years of age * Lansky 50-100% if 10 years of age and under Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: * Bilirubin no greater than 1.5 mg/dL * ALT less than 5 times normal * Albumin at least 2 g/dL Renal: * Creatinine normal for age OR * Glomerular filtration rate normal for age Other: * No uncontrolled infection * No other significant systemic illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior biologic therapy and recovered * At least 1 week since prior growth factors * No prior stem cell transplantation Chemotherapy: * At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered * No more than 2 prior chemotherapy regimens * No other concurrent cancer chemotherapy Endocrine therapy: * Concurrent dexamethasone allowed in patients with CNS tumors provided dose is stable or decreasing for at least 2 weeks prior to study Radiotherapy: * Recovered from prior radiotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) * No prior substantial bone marrow radiotherapy * No prior central axis radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * No concurrent anticonvulsants * No other concurrent anticancer therapy or investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.