Hodgkin's LymphomaPhase 2NCT00838955
Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
A Phase 2 study testing Temsirolimus in people with Hodgkin's Lymphoma, run by Loyola University at 1 site in United States.
Trial summary
This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus has on Hodgkin Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Temsirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2017
- 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 classical Hodgkin Lymphoma or Lymphocyte Predominant Hodgkin Lymphoma with progressive disease during or at the end of the previous therapy, as defined by the IWG criteria.
- Patient must have nodular sclerosing, lymphocyte depleted, or mixed cellularity Hodgkin Lymphoma (Classical Hodgkin Lymphoma), or Lymphocyte predominant Hodgkin Lymphoma.
- Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
- Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging.
- A clearly defined, bidimensionally measurable lymph node or tumor mass measuring at least 2 cm in diameter on a CT scan.
- Patient should have had at least one line of prior chemotherapy. Patients relapsing after treatment with radiation therapy alone are not eligible.
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- Age > than or equal to 18 years.
- Both men and women and members of all races and ethnic groups are eligible for this trial.
- Women must not be pregnant or breast-feeding due to lack of information about the safety of administration of Temsirolimus in pregnant and lactating patients. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
- Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of pregnancy prevention.
- Patient must have a SWOG performance status between 0-2.
- Patient must have no prior treatment with an m-TOR inhibitor.
- Patient must not have active infections at the time of registration.
- Laboratory studies should be obtained within two weeks of study registration except where noted otherwise. Allowable laboratory values are listed below:
- Absolute neutrophil count > than or equal 1,000/mm3
- Hemoglobin > than or equal 8 gm/dL
- Platelets > than or equal 75,000/mm3
- Serum creatinine < than or equal to two times the upper limit of normal. Creatinine should be measured within seven days of registration.
- Total serum bilirubin < than or equal to ≤ 1.5 times the upper limit of normal. Total bilirubin should be measured within seven days of registration.
- AST (SGOT) < than or equal to 3 times the upper limit of normal.
- ALT (SGPT) < than or equal to 3 times the upper limit of normal.
- Fasting total cholesterol < than or equal to 350 mg/dL.
- Fasting triglyceride level < than or equal to 400 mg/dL.
- Patient must have a life expectancy of three months.
Who cannot join
- Patient must not have received prior allogeneic stem cell transplantation. Prior autologous stem cell transplantation more than six months prior to registration is acceptable.
- Patient must not have received prior chemotherapy, biologic therapy or radiation within three weeks prior to registration, and should have recovered from toxicities of prior therapy (to Grade 0 or 1).
- Patient must not have evidence of active CNS disease.
- Patient must not have an uncontrolled comorbid disease, including hyperlipidemia, hypertriglyceridemia, diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Patient must not have a psychiatric illness or social situation that would limit compliance with study requirements.
- Patient must have a life expectancy of three months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153
About this study
This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in patients with Hodgkin Lymphoma who have been previously treated with chemotherapy.
Read the detailed description
Temsirolimus 25 mg IV infusion will be given once weekly on days 1, 8, 15 and 22 of each cycle. Patients will be assessed for response with CT scans after the second cycle, and then after every other cycle until disease progression is confirmed.
Patients will be treated with Temsirolimus until disease progression, or up to six cycles. Continuation of therapy beyond cycles is at the discretion of the investigator.
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Temsirolimus
- Keywords
- Hodgkin's lymphoma, relapsed Hodgkin's lymphoma, refractory Hodgkin's lymphoma, Temsirolimus
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusDrug
Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Temsirolimus | Experimental | Temsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle Receives: Drug: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus
To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus
Measured: 26 weeks
Secondary outcomes (3)
To evaluate the toxicity of temsirolimus in this patient population.
To evaluate the toxicity of temsirolimus in this patient population.
Measured: 26 weeks
To estimate the time to progression after treatment with temsirolimus.
To estimate the time to progression after treatment with temsirolimus.
Measured: 5 years
To estimate overall survival after treatment with temsirolimus.
To estimate overall survival after treatment with temsirolimus.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2016
- Study completionOct 2017
Why it stopped: There was lack of enrollment since January 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Hagen, Patrick A, Loyola University
- Investigators
- Patrick Hagen, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838955
- Sponsor's protocol ID
- 201170
- Status last verified
- Jul 2024
- First submitted
- 6 Feb 2009
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00838955
- Acronym / sponsor ID
- 201170
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Hodgkin's lymphoma, relapsed Hodgkin's lymphoma, refractory Hodgkin's lymphoma, Temsirolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was lack of enrollment since January 2013
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jan 2009
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 9 Feb 2009 (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 clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in patients with Hodgkin Lymphoma who have been previously treated with chemotherapy.
Detailed description
Temsirolimus 25 mg IV infusion will be given once weekly on days 1, 8, 15 and 22 of each cycle. Patients will be assessed for response with CT scans after the second cycle, and then after every other cycle until disease progression is confirmed.
Patients will be treated with Temsirolimus until disease progression, or up to six cycles. Continuation of therapy beyond cycles is at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temsirolimus | Experimental | Drug: TemsirolimusTemsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically confirmed classical Hodgkin Lymphoma or Lymphocyte Predominant Hodgkin Lymphoma with progressive disease during or at the end of the previous therapy, as defined by the IWG criteria.
- Patient must have nodular sclerosing, lymphocyte depleted, or mixed cellularity Hodgkin Lymphoma (Classical Hodgkin Lymphoma), or Lymphocyte predominant Hodgkin Lymphoma.
- Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
- Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging.
- A clearly defined, bidimensionally measurable lymph node or tumor mass measuring at least 2 cm in diameter on a CT scan.
Key exclusion criteria (6 listed)
- Patient must not have received prior allogeneic stem cell transplantation. Prior autologous stem cell transplantation more than six months prior to registration is acceptable.
- Patient must not have received prior chemotherapy, biologic therapy or radiation within three weeks prior to registration, and should have recovered from toxicities of prior therapy (to Grade 0 or 1).
- Patient must not have evidence of active CNS disease.
- Patient must not have an uncontrolled comorbid disease, including hyperlipidemia, hypertriglyceridemia, diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Patient must not have a psychiatric illness or social situation that would limit compliance with study requirements.
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 |
|---|---|---|
| TemsirolimusTemsirolimus 25 mg IV infusion on Days 1, 8, 15, and 22 of a 28 day cycle | Drug | Temsirolimus |
Primary outcome
To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus
Time frame: 26 weeks
To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus
3 secondary outcomes
To evaluate the toxicity of temsirolimus in this patient population.
Time frame: 26 weeks
To estimate the time to progression after treatment with temsirolimus.
Time frame: 5 years
To estimate overall survival after treatment with temsirolimus.
Time frame: 5 years
Results and safety
The study was stopped early (reason given: There was lack of enrollment since January 2013). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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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.
Patrick Hagen, MD principal investigator
Loyola 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 Temsirolimus in people with Hodgkin's Lymphoma, run by Loyola 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 24 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Jul 2024. 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 was stopped early (reason given: There was lack of enrollment since January 2013). Results are not available in the source record.
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?
To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus (time frame: 26 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 10 Jul 2024.