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OpenTrials
Completed

NCT Number: NCT00003234

Vinorelbine in Treating Children With Recurrent or Refractory Cancers

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vinorelbine Tartrate

Drug

Other names: Navelbine®, 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2,3,-dihydroxybutanedioate)

Primary outcomes

  1. Disease progression

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies

Important dates

Study start
1998
Primary completion
2006
Study completion
2007
First posted
Oct 28, 2003
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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