Brain and Central Nervous System TumorsPhase 1NCT00915694
Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme
A Phase 1 study testing nelfinavir mesylate, temozolomide and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- nelfinavir mesylate, temozolomide and adjuvant therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- nelfinavir mesylate, temozolomide, adjuvant therapy, radiation therapy
- Keywords
- adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nelfinavir mesylateDrug
temozolomideDrug
adjuvant therapyProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | NFV-RT-Tem Receives: Drug: nelfinavir mesylate; Drug: temozolomide; Procedure: adjuvant therapy; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of nelfinavir mesylate
Measured: 90 days
Dose-limiting toxicities as assessed by NCI CTC v3.0
Measured: 90 days
Secondary outcomes (2)
Progression-free survival
Measured: One year
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2011
- Study completionDec 2015
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jay F. Dorsey, MD, PhD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915694
- Sponsor's protocol ID
- CDR0000644278
- Other IDs
- UPCC-01309, IRB#809463
- Status last verified
- Apr 2019
- First submitted
- 5 Jun 2009
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
- ClinicalTrials.gov ID
- NCT00915694
- Acronym / sponsor ID
- CDR0000644278
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2009 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: nelfinavir mesylate, Drug: temozolomide, Procedure: adjuvant therapy, Radiation: radiation therapyNFV-RT-Tem |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nelfinavir mesylate | Drug | Single arm |
| temozolomide | Drug | Single arm |
| adjuvant therapy | Procedure or surgery | Single arm |
| radiation therapy | Radiation | Single arm |
Primary outcome
Maximum tolerated dose of nelfinavir mesylate
Time frame: 90 days
Dose-limiting toxicities as assessed by NCI CTC v3.0
Time frame: 90 days
2 secondary outcomes
Progression-free survival
Time frame: One year
Overall survival
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay F. Dorsey, MD, PhD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nelfinavir mesylate, temozolomide and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of nelfinavir mesylate (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.