Clinical trial · Interventional
Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
NCT00038207CI-TRIAL-00035543completedPhase 2ClinicalTrials.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)
The goal of this clinical research study is to learn if treatment with the drug liposomal vincristine can shrink or slow the growth of the patient's cancer. The safety of this drug will also be studied.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Wilms' Tumor | Wilms Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal Vincristine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Liposomal Vincristine
- interventionNames
- Drug: Liposomal Vincristine
Primary outcomes (1)
- measure
- Number of Patients with Response
- timeFrame
- 3 Months post initiation of treatment
- description
- Response defined as Complete Response or Partial Response.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with relapsed malignancies in the following strata: (As of 09/01/02, the soft tissue sarcoma strata will remain open for new patient accrual. Strata listed in b, c, d, e will be closed to entry). 1. soft tissue sarcoma 2. bone sarcoma(CLOSED TO ENTRY AS OF 09/01/02) 3. Wilms tumor(CLOSED TO ENTRY AS OF 09/01/02) 4. lymphoma(CLOSED TO ENTRY AS OF 09/01/02) 5. leukemia(CLOSED TO ENTRY AS OF 09/01/02) * Performance status: Zubrod less than 3. Patients with long standing limited mobility requiring the use of a wheelchair will be considered ambulatory for the purpose of this protocol. * Bidimensionally measurable disease radiologically. * No anti-cancer treatment within the past 3 weeks. * ANC greater than or equal to 500; platelets greater than or equal to 50,000; bilirubin less than or equal to 1.5 mg/dl; SGPT less than or equal to 4 x upper normal limit; creatinine less than or equal to 2 x normal. Patients with bone marrow infiltrative disease may be entered irrespective of ANC or platelets. * Patients may be enrolled after BMT or PSCT if they meet all the above eligibility criteria. Exclusion criteria: * HIV positive. * Serious intercurrent illness, active infections, or second cancer except basal cell carcinoma of the skin or cervical carcinoma in situ. * Eligible for treatment of a higher priority. * Pregnancy. * Grade 3 or 4 sensory or motor dysfunction due to prior vinca alkaloids.
References
Publications (0)
Data not yet available
No reference posted for this study.