NCT00915694

Brief Summary

RATIONALE: Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir mesylate together with radiation therapy and temozolomide may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with radiation therapy and temozolomide in treating patients with glioblastoma multiforme.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_1

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

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

June 5, 2009

Last Update Submit

April 22, 2019

Conditions

Brain and Central Nervous System Tumors

Keywords

adult giant cell glioblastomaadult gliosarcomaadult glioblastoma

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of nelfinavir mesylate

    90 days

  • Dose-limiting toxicities as assessed by NCI CTC v3.0

    90 days

Secondary Outcomes (2)

  • Progression-free survival

    One year

  • Overall survival

    5 years

Study Arms (1)

Single arm

EXPERIMENTAL

NFV-RT-Tem

Drug: nelfinavir mesylateDrug: temozolomideProcedure: adjuvant therapyRadiation: radiation therapy

Interventions

nelfinavir mesylateDRUG
Single arm
temozolomideDRUG
Single arm
adjuvant therapyPROCEDURE
Single arm
radiation therapyRADIATION
Single arm

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed WHO grade IV supratentorial astrocytoma (glioblastoma multiforme) * Newly diagnosed disease * Has undergone maximal surgical resection PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Serum creatinine \< 1.5 times upper limit of normal (ULN) * AST or ALT \< 2 times ULN * Serum bilirubin \< 1.5 mg/dL * No known HIV infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior cranial radiotherapy * More than 30 days since prior investigational agents * No other concurrent investigational agents * No concurrent use of any of the following drugs: * Antiarrhythmics (i.e., amiodarone or quinidine) * Antimycobacterials (i.e., rifampin) * Ergot derivatives (i.e., dihydroergotamine, ergonovine, ergotamine, or methylergonovine) * Herbal products (i.e., St. John's wort) * HMG-CoA reductase inhibitors (i.e., lovastatin or simvastatin) * Neuroleptics (i.e., pimozide) * Sedatives and/or hypnotics (i.e., midazolam or triazolam) * Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥ 14 days prior to study entry

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

NelfinavirTemozolomideChemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Jay F. Dorsey, MD, PhD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 8, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2011

Study Completion

December 1, 2015

Last Updated

April 23, 2019

Record last verified: 2019-04

Locations

US(1)