Back to resultsNelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme
Primary Purpose
Brain and Central Nervous System Tumors
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
nelfinavir mesylate
temozolomide
adjuvant therapy
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma
Eligibility Criteria
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
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
NFV-RT-Tem
Outcomes
Primary Outcome Measures
Maximum tolerated dose of nelfinavir mesylate
Dose-limiting toxicities as assessed by NCI CTC v3.0
Secondary Outcome Measures
Progression-free survival
Overall survival
Full Information
NCT ID
NCT00915694
First Posted
June 5, 2009
Last Updated
April 22, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00915694
Brief Title
Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme
Official Title
A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient accrual
Study Start Date
April 2009 (Actual)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
OBJECTIVES:
Primary
Determine the maximum tolerated dose of nelfinavir mesylate when given concurrently with radiotherapy and temozolomide followed by temozolomide alone in patients with glioblastoma multiforme.
Determine the safety and dose-limiting toxicities of this regimen in these patients.
Secondary
Determine the progression-free survival (PFS) and overall survival (OS) of patients treated with this regimen.
Compare the observed median values of PFS and OS obtained in this study to the historical median values of 6.9 months and 14.6 months, respectively.
OUTLINE: This is a dose-escalation study of nelfinavir mesylate.
Patients receive oral nelfinavir mesylate twice daily beginning 7-10 days before the initiation of chemoradiotherapy and continuing until the completion of chemoradiotherapy. Patients undergo radiotherapy once daily 5 days a week and receive concurrent oral temozolomide once daily for 6 weeks. Beginning 4 weeks after completion of nelfinavir mesylate and chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
NFV-RT-Tem
Intervention Type
Drug
Intervention Name(s)
nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Maximum tolerated dose of nelfinavir mesylate
Time Frame
90 days
Title
Dose-limiting toxicities as assessed by NCI CTC v3.0
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
One year
Title
Overall survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay F. Dorsey, MD, PhD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cancer.gov/clinicaltrials
Description
Clinical trial summary from the National Cancer Institute's PDQ® database
Learn more about this trial
Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme
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