Recurrent Glioblastoma MultiformePhase 2NCT00306618
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
A Phase 2 study testing Panzem Nanocrystal Colloidal Dispersion in people with Recurrent Glioblastoma Multiforme, run by CASI pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma Multiforme
- What is being tested?
- Panzem Nanocrystal Colloidal Dispersion
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2008
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma).
- 18 years or older
- An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks)
- Karnofsky performance score equal to or greater than 70%
- Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters
- Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN
- Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry
- Agree to use effective contraceptive methods
Who cannot join
- Current, active systemic bleeding or excessive risk of bleeding
- Be pregnant or lactating; not employing effective birth control
- Concurrent severe and/or uncontrolled medical disease
- Impairment of gastrointestinal (GI) function/disease
- Requirement for therapy with coumadin (warfarin sodium)
- Patient is less than 5 years free of another primary malignancy
- Patients unwilling to or unable to comply with the protocol
- Grade 2 or greater peripheral sensory neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Brain Tumor Center, Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme
This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)
- Conditions
- Recurrent Glioblastoma Multiforme
- Being tested
- Panzem Nanocrystal Colloidal Dispersion
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panzem Nanocrystal Colloidal DispersionDrug
Also called 2-methoxyestradiol, 2ME2
Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month progression free survival and median overall survival
Measured: time of progression; survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionNov 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Glioblastoma MultiformeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David A. Reardon, M.D., Principal investigator, The Brain Center at Duke, Duke University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306618
- Sponsor's protocol ID
- ME-CLN-005
- Status last verified
- Dec 2008
- First submitted
- 22 Mar 2006
- Last updated
- 10 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00306618
- Acronym / sponsor ID
- ME-CLN-005
- Conditions
- Recurrent Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Mar 2006 (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.
This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma).
- 18 years or older
- An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks)
- Karnofsky performance score equal to or greater than 70%
- Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters
Key exclusion criteria (8 listed)
- Current, active systemic bleeding or excessive risk of bleeding
- Be pregnant or lactating; not employing effective birth control
- Concurrent severe and/or uncontrolled medical disease
- Impairment of gastrointestinal (GI) function/disease
- Requirement for therapy with coumadin (warfarin sodium)
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 |
|---|---|---|
| Panzem Nanocrystal Colloidal DispersionAlso: 2-methoxyestradiol, 2ME2Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing | Drug | – |
Primary outcome
6 month progression free survival and median overall survival
Time frame: time of progression; survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2008.
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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.
David A. Reardon, M.D. principal investigator
The Brain Center at Duke, Duke University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panzem Nanocrystal Colloidal Dispersion in people with Recurrent Glioblastoma Multiforme, run by CASI pharmaceuticals, Inc. 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?
The sponsor lists 8 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 10 Dec 2008. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
6 month progression free survival and median overall survival (time frame: time of progression; survival). 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 10 Dec 2008; AzTrials last refreshed its copy on 8 Nov 2026.