GliomaPhase 1NCT00080054
A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
A Phase 1 study testing Motexafin Gadolinium Injection in people with Glioma and Glioblastoma, run by Pharmacyclics LLC. at 1 site in United States.
Trial summary
The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma, Astrocytoma
- What is being tested?
- Motexafin Gadolinium Injection
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma)
- ECOG performance status score of 0, 1, or 2
- Each patient must sign a study-specific informed consent form
Who cannot join
- Laboratory values of:
- Absolute neutrophil count < 2000/µL
- Platelet count < 100,000/µL
- AST or ALT > 2 x the upper limit of normal (ULN)
- Alkaline phosphatase > 5 x ULN
- Bilirubin > 2 x ULN
Show all 10Show fewer
- Creatinine > 2.0 mg/µL
- and
- Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period
- Women who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
Official title: Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas
The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.
- Conditions
- Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Neoplasm
- Being tested
- Motexafin Gadolinium Injection
- Keywords
- Malignant Glioma, Glioblastoma multiforme, GBM, Anaplastic astrocytoma, AA, Anaplastic oligodendroglioma, Anaplastic mixed glioma, Brain tumor, Brain neoplasm, Glioma
- Medical subject headings
- Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motexafin Gadolinium InjectionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080054
- Sponsor's protocol ID
- PCYC-0218
- Status last verified
- Jan 2007
- First submitted
- 22 Mar 2004
- Last updated
- 3 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas
- ClinicalTrials.gov ID
- NCT00080054
- Acronym / sponsor ID
- PCYC-0218
- Conditions
- Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Neoplasm
- Keywords
- Malignant Glioma, Glioblastoma multiforme, GBM, Anaplastic astrocytoma, AA, Anaplastic oligodendroglioma, Anaplastic mixed glioma, Brain tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- First posted
- 23 Mar 2004 (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 find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.
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 (4 listed)
- At least 18 years old
- Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma)
- ECOG performance status score of 0, 1, or 2
- Each patient must sign a study-specific informed consent form
Key exclusion criteria (10 listed)
- Absolute neutrophil count < 2000/µL
- Platelet count < 100,000/µL
- AST or ALT > 2 x the upper limit of normal (ULN)
- Alkaline phosphatase > 5 x ULN
- Bilirubin > 2 x ULN
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 |
|---|---|---|
| Motexafin Gadolinium Injection | Drug | – |
Primary outcome
Not reported in the source record.
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 3 Apr 2009.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Motexafin Gadolinium Injection in people with Glioma and Glioblastoma, run by Pharmacyclics LLC. 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 4 inclusion and 10 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 3 Apr 2009. 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 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.
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 3 Apr 2009.