NCT00075491

Brief Summary

This randomized phase II trial is studying how well neoadjuvant and adjuvant fenretinide works compared to adjuvant fenretinide alone in treating patients who are undergoing surgical resection for recurrent glioblastoma multiforme. Chemotherapy drugs, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether neoadjuvant and adjuvant fenretinide is more effective than adjuvant fenretinide alone

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

January 9, 2004

Last Update Submit

January 23, 2013

Conditions

Adult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaRecurrent Adult Brain Tumor

Outcome Measures

Primary Outcomes (5)

  • Progression-free survival (PFS)

    Up to 6 months

  • Plasma and tissue concentrations of fenretinide and its metabolite, 4-MPR using high-performance liquid chromatography (HPLC) assay

    At baseline, and at 1, 7, 14, and 21 days

  • Tumor apoptotic index after fenretinide treatment by immunohistochemistry

    At the time of surgery

  • Correlation between tumor apoptotic index with serum and tissue fenretinide levels

    At the time of surgery

  • Correlation of time to progression with drug levels and apoptotic index

    Up to 2 years

Secondary Outcomes (5)

  • Fenretinide effects on retinol, RBP, retinoid receptor levels and IGF-1

    Up to 21 days (course 1 and 4)

  • Fenretinide activity using magnetic resonance spectroscopy (MRS)

    At the time of surgery

  • Radiological response

    Up to 2 years

  • Overall survival

    Up to 2 years

  • Unexpected toxicity associated with fenretinide as assessed by CTC version 3.0

    Up to 2 years

Study Arms (2)

Arm I (fenretinide, surgery)

EXPERIMENTAL

Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection.

Drug: fenretinideProcedure: therapeutic conventional surgeryOther: pharmacological studyOther: laboratory biomarker analysis

Arm II (surgery)

ACTIVE COMPARATOR

Patients undergo surgical resection.

Procedure: therapeutic conventional surgeryOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

fenretinideDRUG

Given orally

Also known as: fenretinimide, McN-R-1967
Arm I (fenretinide, surgery)
therapeutic conventional surgeryPROCEDURE

Undergo surgery

Arm I (fenretinide, surgery)Arm II (surgery)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm I (fenretinide, surgery)Arm II (surgery)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (fenretinide, surgery)Arm II (surgery)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed glioblastoma multiforme after initial tumor resection
  • Radiologically evident recurrent tumor after prior radiotherapy OR after treatment for no more than 2 prior relapses
  • Enhancing or nonenhancing recurrent disease by MRI
  • No progressive symptoms requiring urgent surgery
  • Performance status - Karnofsky 70-100%
  • More than 8 weeks
  • Absolute granulocyte count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • PT/PTT no greater than upper limit of normal
  • SGPT no greater than 2.5 times normal
  • Alkaline phosphatase no greater than 2.5 times normal
  • Bilirubin less than 1.5 mg/dL
  • BUN no greater than 1.5 times normal
  • Creatinine no greater than 1.5 times normal
  • Not pregnant or nursing
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

GlioblastomaGliosarcomaBrain Neoplasms

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Vinay K. Puduvalli

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 12, 2004

Study Start

December 1, 2003

Primary Completion

March 1, 2005

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)