Myeloid LeukemiasPhase 1UPCC 02407NCT00780104
Sirolimus in Combination With MEC in High Risk Myeloid Leukemias
A Phase 1 study testing Rapamycin, Mitoxantrone, Etoposide, Cytarabine and Rapamycin + MEC in people with Myeloid Leukemias and AML, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk myeloid leukemias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemias, AML, Leukemia
- What is being tested?
- Rapamycin, Mitoxantrone, Etoposide, Cytarabine and Rapamycin + MEC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2010
- 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
- Must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-M3 AML; relapsed non-M3 AML; secondary AML; intermediate or poor prognosis de novo AML in patients who are >= 60 years old
- >= 18 years of age
- ECOG performance status of 0, 1
- Able to consume oral medication
- Initial laboratory values: creatinine <= 2.0 mg/dL; total or direct bilirubin <= 1.5/dL; SGPT(ALT) <= 3xULN; negative pregnancy test for women with child-bearing potential
- Ejection fraction of >= 45%
Who cannot join
- Subjects with FAM B3
- Must not be receiving chemotherapy (except Hydroxyurea)
- Not receiving growth factors, except for erythropoietin
- Subjects with a "currently active" second malignancy other than non-melanoma skin cancers
- Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or uncontrolled cardiac arrhythmia
- Subjects taking diltiazem
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- Subjects who require HIV protease inhibitors or those with AIDS-related illnesses
- No evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy
- Not pregnant or breastfeeding
- Uncontrolled infection
- Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias
The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk myeloid leukemias.
- Conditions
- Myeloid Leukemias, AML, Leukemia, CML
- Being tested
- Rapamycin, Mitoxantrone, Etoposide, Cytarabine, Rapamycin + MEC
- Keywords
- Advanced myeloid leukemias, AML, Leukemia, Relapsed myeloid leukemias, Refractory myeloid leukemias, MEC, Rapamycin, Sirolimus
- Medical subject headings
- Leukemia, Myeloid, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin, Mitoxantrone, Etoposide, CytarabineDrug
Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.
Rapamycin + MECDrug
Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin + MEC | Experimental | Not described Receives: Drug: Rapamycin, Mitoxantrone, Etoposide, Cytarabine; Drug: Rapamycin + MEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells
Measured: Study conclusion
Secondary outcomes (1)
Safety of the sirolimus + MEC regimen
Measured: Study conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid LeukemiasStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780104
- Sponsor's protocol ID
- UPCC 02407
- Acronym
- UPCC 02407
- Status last verified
- Jul 2019
- First submitted
- 24 Oct 2008
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias
- ClinicalTrials.gov ID
- NCT00780104
- Acronym / sponsor ID
- UPCC 02407 / UPCC 02407
- Conditions
- Myeloid Leukemias, AML, Leukemia, CML
- Keywords
- Advanced myeloid leukemias, AML, Leukemia, Relapsed myeloid leukemias, Refractory myeloid leukemias, MEC, Rapamycin, Sirolimus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Oct 2008 (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 side effects of sirolimus (rapamycin) given in combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk myeloid leukemias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapamycin + MEC | Experimental | Drug: Rapamycin, Mitoxantrone, Etoposide, Cytarabine, Drug: Rapamycin + MEC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-M3 AML; relapsed non-M3 AML; secondary AML; intermediate or poor prognosis de novo AML in patients who are >= 60 years old
- >= 18 years of age
- ECOG performance status of 0, 1
- Able to consume oral medication
- Initial laboratory values: creatinine <= 2.0 mg/dL; total or direct bilirubin <= 1.5/dL; SGPT(ALT) <= 3xULN; negative pregnancy test for women with child-bearing potential
Key exclusion criteria (11 listed)
- Subjects with FAM B3
- Must not be receiving chemotherapy (except Hydroxyurea)
- Not receiving growth factors, except for erythropoietin
- Subjects with a "currently active" second malignancy other than non-melanoma skin cancers
- Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or uncontrolled cardiac arrhythmia
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 |
|---|---|---|
| Rapamycin, Mitoxantrone, Etoposide, CytarabineRapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus. | Drug | Rapamycin + MEC |
| Rapamycin + MECRapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus. | Drug | Rapamycin + MEC |
Primary outcome
Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells
Time frame: Study conclusion
1 secondary outcome
Safety of the sirolimus + MEC regimen
Time frame: Study conclusion
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 12 Jul 2019.
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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 Rapamycin, Mitoxantrone, Etoposide, Cytarabine and Rapamycin + MEC in people with Myeloid Leukemias and AML, 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?
The sponsor lists 6 inclusion and 11 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 12 Jul 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 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?
Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells (time frame: Study conclusion). 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 12 Jul 2019.