Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink or slow the growth of pediatric low-grade gliomas that have either returned or are continuing to grow.
Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its therapeutic spectrum and decrease the neurotoxicity associated with related agents.
| Condition | Intervention | Phase |
|---|---|---|
|
Low-grade Glioma |
Drug: Weekly vinorelbine treatment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas |
- Progression-free survival [ Time Frame: Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or date off study. This will be assessed continually for 60 months. ] [ Designated as safety issue: No ]
- Quality of life assessments [ Time Frame: Assessed yearly for the 60 months. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2019 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vinorelbine |
Drug: Weekly vinorelbine treatment
Vinorelbine will be administered IV once a week for 6 out of every 8 weeks. This will continue barring progression or unacceptable toxicity for at least one year.
|
Detailed Description:
Different treatments exist for children with progressive or recurrent low-grade glioma. Each has variable efficacy at slowing or reversing growth, and exploration continues into finding better-tolerated, more effective treatments.
Vinorelbine has recently generated interest in stabilizing some pediatric low-grade gliomas. It has been fairly well tolerated in both adult and pediatric studies that have examined its use in other tumors.
In addition, the quality of life for children with low-grade gliomas is important and requires further study. This trial will incorporate an optional assessment using validated neuropsychological testing throughout treatment to evaluate the quality of life of the child being treated.
Objective: To test the efficacy of Vinorelbine in a larger number of children with pediatric low-grade glioma that has returned or continues to grow.
In this trial, Vinorelbine will be given intravenously once a week for 6 weeks followed by a 2 week rest. This cycle can then be repeated for up to 1-2 years if providing clinical benefit.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: < 18 years
- Tumor: Progressive or recurrent low grade glioma, WHO grade 1 or 2 who have failed at least one form of 'conventional' non-surgical therapy
- Histologic confirmation is required with the exception of optic pathway and brain stem gliomas. Patients are not required to have a re-operation at time of recurrence.
- Patients with disseminated disease are eligible.
- Children with neuro-fibromatosis and optic pathway or brainstem tumors are eligible but must have definitive radiologic or clinical evidence of progression
- Patients must have evidence of measureable disease
- Performance status: Karnofsky or Lansky performance status of >50%
- Organ Function:
- Adequate bone marrow function (ANC>1000/mm3, platelet count of >75,000/mm3, and hemoglobin > 8gm/dL) prior to starting therapy. Hemoglobin may be supported by transfusion
- Adequate liver function (SGPT/ALT<2.5 times ULN and bilirubin < 1.5 times ULN) prior to starting therapy
- Prior therapy:
- May have had treatment including surgery, chemotherapy, or radiotherapy for any number of relapses prior to enrollment
- Patients must have received their last fraction of radiotherapy >12 weeks prior to starting therapy
- Previous Vincristine or Vinblastine exposure is allowable.
Exclusion Criteria:
- No other significant medical illness that in the investigators' opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- Any other cancer (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
- Patients of childbearing potential must not be pregnant or breast-feeding (vinorelbine is a pregnancy category D, no data on excretion in breastmilk)
- Patients of childbearing or fathering potential must practice adequate contraception
Contacts and Locations| Contact: Eugene Hwang, MD | 202-476-5046 | ehwang@childrensnational.org |
| Contact: Alissa Mun | 202-476-5546 | amun@childrensnational.org |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Eugene Hwang, MD 202-476-5046 ehwang@childrensnational.org | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Amulya Rao, MBBS 507-284-2652 NageswaraRao.Amulya@mayo.edu | |
| Principal Investigator: Amulya Rao, MBBS | |
| Principal Investigator: | Eugene Hwang, MD | Children's Research Institute |
More Information
No publications provided
| Responsible Party: | Eugene Hwang, Assistant Professor, Pediatric Oncology, Children's Research Institute |
| ClinicalTrials.gov Identifier: | NCT01497860 History of Changes |
| Other Study ID Numbers: | CNMC-VRL |
| Study First Received: | December 16, 2011 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Research Institute:
|
pediatric children glioma low-grade |
vinorelbine recurrent progressive |
Additional relevant MeSH terms:
|
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve 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 19, 2013