Central Nervous System NeoplasmsPhase 1NCT00328458
EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients
A Phase 1 study testing EPO906 (epothilone B) in people with Central Nervous System Neoplasms and Head and Neck Neoplasms, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Neoplasms, Head and Neck Neoplasms
- What is being tested?
- EPO906 (epothilone B)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jul 2009
- 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
- Requires a minimum of 3 weeks of radiation therapy
- Solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy
- World Health Organization (WHO) performance status equal to or less than 2
- Life expectancy equal to or greater than 3 months
Who cannot join
- Any peripheral neuropathy
- Unresolved diarrhea greater than grade 1
- Patients who received any other investigational compound within the past 28 days
- Severe cardiac insufficiency
- Patients on Coumadin
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer
The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.
Read the detailed description
- To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose.
- To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts.
- To evaluate tumor response.
- Being tested
- EPO906 (epothilone B)
- Keywords
- CNS and head and neck cancers, Histologically confirmed CNS malignancy head and neck, there is on standard therapy or, have failed standard therapy
- Medical subject headings
- Central Nervous System Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPO906 (epothilone B)Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Brain Tumors | Experimental | The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort. Receives: Drug: EPO906 (epothilone B) |
| Cohort 2 Head and Neck Tumors | Experimental | The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort. Receives: Drug: EPO906 (epothilone B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of EPO906
Measured: Baseline to 7 weeks
Secondary outcomes (1)
Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy
Measured: Baseline to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startFeb 2004
- Primary completionMay 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Adam Dicker, MD, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328458
- Sponsor's protocol ID
- 03C.275
- Other IDs
- 2003-33, JT 1035
- Status last verified
- May 2025
- First submitted
- 19 May 2006
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer
- ClinicalTrials.gov ID
- NCT00328458
- Acronym / sponsor ID
- 03C.275
- Keywords
- CNS and head and neck cancers, Histologically confirmed CNS malignancy head and neck, there is on standard therapy or, have failed standard therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Feb 2004
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 May 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.
The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.
Detailed description
- To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose.
- To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts.
- To evaluate tumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Brain Tumors | Experimental | Drug: EPO906 (epothilone B)The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort. |
| Cohort 2 Head and Neck Tumors | Experimental | Drug: EPO906 (epothilone B)The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Requires a minimum of 3 weeks of radiation therapy
- Solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy
- World Health Organization (WHO) performance status equal to or less than 2
- Life expectancy equal to or greater than 3 months
Key exclusion criteria (5 listed)
- Any peripheral neuropathy
- Unresolved diarrhea greater than grade 1
- Patients who received any other investigational compound within the past 28 days
- Severe cardiac insufficiency
- Patients on Coumadin
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 |
|---|---|---|
| EPO906 (epothilone B) | Drug | Cohort 1 Brain Tumors, Cohort 2 Head and Neck Tumors |
Primary outcome
Maximum tolerated dose (MTD) of EPO906
Time frame: Baseline to 7 weeks
1 secondary outcome
Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy
Time frame: Baseline to 7 weeks
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 2 May 2025.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink 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.
Adam Dicker, MD, PhD principal investigator
Thomas Jefferson University
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 EPO906 (epothilone B) in people with Central Nervous System Neoplasms and Head and Neck Neoplasms, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 5 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 2 May 2025. 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.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of EPO906 (time frame: Baseline to 7 weeks). 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 2 May 2025.