Clinical trial · Interventional
A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)
A Study to Document Long-term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects 1 - 21 Years of Age With Refractory Solid Tumors Who Have Experienced Clinical Benefit Following a Minimum of 6 Cycles of Therapy on BMS Protocol CA124-001 or BMS Protocol CA124-002
- 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)
The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.
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 |
|---|---|---|---|
| Pediatric Solid Tumors | Childhood Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Carboplatin
- interventionNames
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Irinotecan (12 (9) mg/m²/day)
- interventionNames
- Drug: Irinotecan
- type
- ACTIVE_COMPARATOR
- label
- Irinotecan (10 (10) mg/m²/day
- interventionNames
- Drug: Irinotecan
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy * Karnofsky score of at least 50 for subjects \> 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger * Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies * Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002 Exclusion Criteria: * A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy * Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study * Inadequate bone marrow and renal function * Concurrent receipt of Dilantin®(phenytoin), phenobarbital, primidone, Tegretol®(carbamazepine), Depacon®, Depakene®, Depakote®, and Deproic®(valproic acid)
References
Publications (0)
Data not yet available