Vinorelbine in Treating Children With Recurrent or Refractory Cancers
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Neuroblastoma Sarcoma |
Drug: vinorelbine tartrate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies |
| Study Start Date: | May 1998 |
OBJECTIVES: I. Determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine. II. Assess the toxic effects of this drug in these children.
OUTLINE: Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6. Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory solid malignant tumors of childhood including: Soft tissue sarcoma Rhabdomyosarcoma Nonrhabdomyosarcoma Extraosseous Ewing's sarcoma CNS tumors Astrocytoma Primitive neuroectodermal tumor Atypical teratoid/rhabdoid tumors Ependymoma Recurrent neuroblastoma Measurable disease No more than 2 prior treatment regimens
PATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: For patients with solid tumors (unless marrow involvement): Absolute neutrophil count (ANC) at least 1000/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) For patients post bone marrow transplantation: ANC at least 1,000/mm3 Platelet count at least 50,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) Hepatic: Total bilirubin no greater than 1.5 times normal SGOT/SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Neurologic: Seizure disorder allowed if well controlled CNS toxicity no greater than grade 2
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior bone marrow transplantation No concurrent immunomodulating agents Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for increased intracranial pressure due to CNS tumors Radiotherapy: At least 6 months since prior radiotherapy to craniospinal axis, spine, and/or more than 50% of the bony pelvis Concurrent radiotherapy to localized painful lesions allowed if at least one measurable lesion is not in radiation field Surgery: Not specified Other: No concurrent participation in another CCG, POG, or COG therapeutic study
Contacts and Locations
Show 228 Study Locations| Study Chair: | John F. Kuttesch, PhD, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003234 History of Changes |
| Other Study ID Numbers: | CDR0000066106, COG-A09705, CCG-09705 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 26, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent childhood rhabdomyosarcoma recurrent neuroblastoma recurrent childhood soft tissue sarcoma recurrent childhood supratentorial primitive neuroectodermal tumor |
recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent childhood ependymoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Neuroblastoma Central Nervous System Neoplasms Sarcoma Neoplasms by Site Neoplasms Nervous System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Connective and Soft Tissue Vinorelbine Vinblastine Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013