Recurrent Glioblastoma MultiformePhase 2NCT00481455
Phase 2 Study of Panzem Nanocrystal Colloidal Dispersion (NCD) in Combination With Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme (GBM)
A Phase 2 study testing Panzem NCD and Temozolomide in people with Recurrent Glioblastoma Multiforme, run by CASI pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the anti-tumor activity and safety of Panzem NCD given in combination with daily oral fixed-dose temozolomide in patients with recurrent glioblastoma multiforme. 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 NCD and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Oct 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
- A histologically confirmed diagnosis of a recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma). Patients with recurrent disease whose diagnostic pathology confirmed WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) will not need re-biopsy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO grade IV malignant glioma. Pathology must be confirmed at Duke University Medical Center
- Male or female, aged greater than or equal to 18 years.
- An interval of at least 2 weeks between prior surgical resection (if conducted) or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks) and enrollment in this protocol unless there is unequivocal evidence of tumor progression and the patient has recovered from toxicities associated with those therapies. However, patients treated with chemotherapeutic agents such as VP-16 who would normally be retreated after shorter intervals (e.g. 21 days on, 7 days off schedule) may be treated at the usual starting time even if less than 4 weeks from the last prior dose of chemotherapy.
- Karnofsky performance score greater than or equal to 70%.
- Hematocrit > 29%, absolute neutrophil count > 1,500 cells/*L, platelets > 100,000 cells/*L.
- Serum creatinine < 1.5 X upper limit of normal (ULN), serum glutamic oxaloacetic transaminase < 2.5 X ULN; and bilirubin < 1.5 times ULN.
- Signed informed consent form and authorization for use and disclosure of protected health information approved by the Institutional Review Board (IRB) prior to patient entry.
- If sexually active, patients must use contraceptive measures for the duration of the treatments and for 4 weeks following end of study medication.
Who cannot join
- Current, active systemic bleeding or excessive risk of bleeding as defined by the following: stroke within the previous 6 months, history of central nervous system or intraocular bleed, history of septic endocarditis or evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post operative grade 1 hemorrhage.
- Female patients who are pregnant or breastfeeding or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative pregnancy test within 48 hours prior to administration of study medication).
- Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease, or active uncontrolled infection) that could compromise participation in the study.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the liquid).
- Requirement for therapy with coumadin (warfarin sodium).
- Patient is < 1 year free of another primary malignancy except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
- 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 and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With Protracted Oral Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme
The purpose of this study is to evaluate the anti-tumor activity and safety of Panzem NCD given in combination with daily oral fixed-dose temozolomide in patients with recurrent glioblastoma multiforme.
- Conditions
- Recurrent Glioblastoma Multiforme
- Being tested
- Panzem NCD, Temozolomide
- Keywords
- Glioblastoma Multiforme, temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panzem NCDDrug
Also called 2-methoxyestradiol, 2ME2
2000 mg q8h, continuous dosing in 28 day cycles
TemozolomideDrug
Fixed dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Panzem NCD; Drug: Temozolomide |
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 for patients receiving at least one dose
Measured: Every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2007
- Study completionOct 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Annick Desjardins, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481455
- Sponsor's protocol ID
- ME-CLN-007
- Status last verified
- Nov 2008
- First submitted
- 30 May 2007
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Phase II, Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With Protracted Oral Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00481455
- Acronym / sponsor ID
- ME-CLN-007
- Conditions
- Recurrent Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme, temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Jun 2007 (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.
The purpose of this study is to evaluate the anti-tumor activity and safety of Panzem NCD given in combination with daily oral fixed-dose temozolomide in patients with recurrent glioblastoma multiforme.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Panzem NCD, Drug: Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A histologically confirmed diagnosis of a recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma). Patients with recurrent disease whose diagnostic pathology confirmed WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) will not need re-biopsy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO grade IV malignant glioma. Pathology must be confirmed at Duke University Medical Center
- Male or female, aged greater than or equal to 18 years.
- An interval of at least 2 weeks between prior surgical resection (if conducted) or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks) and enrollment in this protocol unless there is unequivocal evidence of tumor progression and the patient has recovered from toxicities associated with those therapies. However, patients treated with chemotherapeutic agents such as VP-16 who would normally be retreated after shorter intervals (e.g. 21 days on, 7 days off schedule) may be treated at the usual starting time even if less than 4 weeks from the last prior dose of chemotherapy.
- Karnofsky performance score greater than or equal to 70%.
- Hematocrit > 29%, absolute neutrophil count > 1,500 cells/*L, platelets > 100,000 cells/*L.
Key exclusion criteria (8 listed)
- Current, active systemic bleeding or excessive risk of bleeding as defined by the following: stroke within the previous 6 months, history of central nervous system or intraocular bleed, history of septic endocarditis or evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post operative grade 1 hemorrhage.
- Female patients who are pregnant or breastfeeding or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative pregnancy test within 48 hours prior to administration of study medication).
- Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease, or active uncontrolled infection) that could compromise participation in the study.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the liquid).
- 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 NCDAlso: 2-methoxyestradiol, 2ME22000 mg q8h, continuous dosing in 28 day cycles | Drug | 1 |
| TemozolomideFixed dose | Drug | 1 |
Primary outcome
6-month progression free survival and median overall survival for patients receiving at least one dose
Time frame: Every 2 cycles
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 25 Nov 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.
Annick Desjardins, MD principal investigator
Duke University
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 NCD and Temozolomide 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 25 Nov 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 for patients receiving at least one dose (time frame: Every 2 cycles). 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 25 Nov 2008.