LeukemiaPhase 1NCT00968461
Study of Phenethyl Isothiocyanate in Lymphoproliferative Disorders
A Phase 1 study testing Phenethyl Isothiocyanate (PEITC) in people with Leukemia and Lymphoproliferative Disorders, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn the highest tolerable dose of phenethyl isothiocyanate (PEITC) that can be given to patients who have a lymphoproliferative disorder that has been treated with fludarabine. The safety of PEITC will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphoproliferative Disorders
- What is being tested?
- Phenethyl Isothiocyanate (PEITC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2013to May 2015
- 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
- All patients with a histologically or cytologically confirmed lymphoproliferative disorder previously treated with fludarabine are eligible for this protocol.
- Patients must be 18 years of age or older.
- Patients must have a performance status of 0-2 (Zubrod scale).
- Patients must have adequate renal function (serum creatinine </= 2 mg/dL or creatinine clearance > 50 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the P.I. and consideration of appropriate dose adjustments.
- Patients must have adequate function (bilirubin </= 2.0 mg/dl; SGOT or SGPT </= 3X the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder [for bilirubin]). Patients with hepatic dysfunction due to organ infiltration by disease may be eligible after discussion with the P.I. and consideration of appropriate dose adjustments.
- Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Who cannot join
- Untreated or uncontrolled life-threatening infection (Grade 4 infection, i.e. septic shock, hypotension, acidosis, necrosis).
- Pregnancy or breastfeeding. Female patients of childbearing potential (including those <1 year postmenopausal) and male patients must agree to use contraception. A female of child bearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Chemotherapy and/or radiation therapy within 4 weeks of study enrollment.
- Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results.
About this study
Official title: A Phase I Study of Phenethyl Isothiocyanate (PEITC) in Patients With Lymphoproliferative Disorders Previously Treated With Fludarabine
The goal of this clinical research study is to learn the highest tolerable dose of phenethyl isothiocyanate (PEITC) that can be given to patients who have a lymphoproliferative disorder that has been treated with fludarabine. The safety of PEITC will also be studied.
Read the detailed description
The Study Drug:
PEITC is designed to cause build-up of specific molecules in cells, which may damage cancer cells and cause the cells to die.
Study Drug Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of PEITC based on when you joined this study. Up to 9 dose levels of PEITC will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of PEITC is found.
Study Drug Administration:
Every 28 days in this study is 1 "cycle." You will take PEITC capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle. You should take each dose with a cup (8 ounces) of water, either with or without food. The doses should be taken at the same times each day (about 7:00 AM, 12 noon, 5:00 PM, and 10:00 PM).
Study Visits:
Once a week, blood (about 1 tablespoon each time) will be drawn for routine tests. These weekly blood draws will occur on Days 1, 8, 15, and 21 of each cycle, +/- 3 days.
Follow-up After Completion of Cycle 3:
Four (4) weeks after the start of the third cycle, the following tests and procedures will be performed:
- You will have a complete physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Blood (about 1 tablespoon) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a bone marrow aspiration, fine-needle aspiration (FNA), and/or biopsy in order to check the status of the disease.
PK and PD Testing:
This study involves blood draws for pharmacokinetic (PK) and pharmacodynamic (PD) testing. PK testing measures the amount of study drug in the body at different time points. PD testing is used to look at how the level of study drug in your body may affect the disease.
Blood (about 1 tablespoon each time) will be drawn and used for both of these tests, on the following schedule:
- Day 1 of Cycle 1 (or possibly the day before Day 1)
- Days 1, 2, and 3 of Cycle 1 (at 4 hours after that day's first dose of PEITC)
- Day 4 of Cycle 1 (at 12 hours after your last dose of PEITC)
Length of Study Participation:
You may receive up to 6 cycles (24 weeks) of the study drug. You will be taken off the study drug early if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
At the end of your last study cycle, you will have a complete physical exam, including measurement of your vital signs.
In addition, unless the disease has completely responded, the following tests and procedures will be performed at the end-of-study visit:
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a bone marrow aspiration and/or biopsy to check the status of the disease, if the study doctor thinks it is necessary.
Follow-Up Visits:
Every 3 to 6 months after the end of your last study cycle, you will have a bone marrow aspiration and/or biopsy if the study doctor thinks it is necessary to check the status of the disease in this way.
Every 3 to 6 months after the end of your last study cycle, you will have a complete physical exam, including measurement of vital signs.
After the follow-up visit at 24 weeks after the end of your last study cycle, the schedule of your follow-up physical exams will be every 3 to 6 months. These visits may include a blood draw and bone marrow aspiration. Your study doctor will decide if these tests are needed. If the disease returns during this time, however, you will be considered off-study. This means you will also no longer have the follow-up bone marrow samples collected as part of this study.
This is an investigational study. PEITC is not commercially available or FDA approved. At this time, it is only being used in research.
Up to 54 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Leukemia, Lymphoproliferative Disorders
- Being tested
- Phenethyl Isothiocyanate (PEITC)
- Keywords
- Chronic lymphocytic leukemia, CLL, PEITC, Phenethyl Isothiocyanate, Fludarabine
- Medical subject headings
- Leukemia, Lymphoproliferative Disorders, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenethyl Isothiocyanate (PEITC)Drug
Starting dose 40 mg capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Phenethyl Isothiocyanate (PEITC) | Experimental | Starting dose 40 mg capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle. Receives: Drug: Phenethyl Isothiocyanate (PEITC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: 28 Day Cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Apostolia M. Tsimberidou, MD, PHD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968461
- Sponsor's protocol ID
- 2007-0622
- Status last verified
- Apr 2013
- First submitted
- 28 Aug 2009
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Phenethyl Isothiocyanate (PEITC) in Patients With Lymphoproliferative Disorders Previously Treated With Fludarabine
- ClinicalTrials.gov ID
- NCT00968461
- Acronym / sponsor ID
- 2007-0622
- Conditions
- Leukemia, Lymphoproliferative Disorders
- Keywords
- Chronic lymphocytic leukemia, CLL, PEITC, Phenethyl Isothiocyanate, Fludarabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- First posted
- 31 Aug 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.
The goal of this clinical research study is to learn the highest tolerable dose of phenethyl isothiocyanate (PEITC) that can be given to patients who have a lymphoproliferative disorder that has been treated with fludarabine. The safety of PEITC will also be studied.
Detailed description
The Study Drug:
PEITC is designed to cause build-up of specific molecules in cells, which may damage cancer cells and cause the cells to die.
Study Drug Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of PEITC based on when you joined this study. Up to 9 dose levels of PEITC will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of PEITC is found.
Study Drug Administration:
Every 28 days in this study is 1 "cycle." You will take PEITC capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle. You should take each dose with a cup (8 ounces) of water, either with or without food. The doses should be taken at the same times each day (about 7:00 AM, 12 noon, 5:00 PM, and 10:00 PM).
Study Visits:
Once a week, blood (about 1 tablespoon each time) will be drawn for routine tests. These weekly blood draws will occur on Days 1, 8, 15, and 21 of each cycle, +/- 3 days.
Follow-up After Completion of Cycle 3:
Four (4) weeks after the start of the third cycle, the following tests and procedures will be performed:
- You will have a complete physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Blood (about 1 tablespoon) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a bone marrow aspiration, fine-needle aspiration (FNA), and/or biopsy in order to check the status of the disease.
PK and PD Testing:
This study involves blood draws for pharmacokinetic (PK) and pharmacodynamic (PD) testing. PK testing measures the amount of study drug in the body at different time points. PD testing is used to look at how the level of study drug in your body may affect the disease.
Blood (about 1 tablespoon each time) will be drawn and used for both of these tests, on the following schedule:
- Day 1 of Cycle 1 (or possibly the day before Day 1)
- Days 1, 2, and 3 of Cycle 1 (at 4 hours after that day's first dose of PEITC)
- Day 4 of Cycle 1 (at 12 hours after your last dose of PEITC)
Length of Study Participation:
You may receive up to 6 cycles (24 weeks) of the study drug. You will be taken off the study drug early if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
At the end of your last study cycle, you will have a complete physical exam, including measurement of your vital signs.
In addition, unless the disease has completely responded, the following tests and procedures will be performed at the end-of-study visit:
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a bone marrow aspiration and/or biopsy to check the status of the disease, if the study doctor thinks it is necessary.
Follow-Up Visits:
Every 3 to 6 months after the end of your last study cycle, you will have a bone marrow aspiration and/or biopsy if the study doctor thinks it is necessary to check the status of the disease in this way.
Every 3 to 6 months after the end of your last study cycle, you will have a complete physical exam, including measurement of vital signs.
After the follow-up visit at 24 weeks after the end of your last study cycle, the schedule of your follow-up physical exams will be every 3 to 6 months. These visits may include a blood draw and bone marrow aspiration. Your study doctor will decide if these tests are needed. If the disease returns during this time, however, you will be considered off-study. This means you will also no longer have the follow-up bone marrow samples collected as part of this study.
This is an investigational study. PEITC is not commercially available or FDA approved. At this time, it is only being used in research.
Up to 54 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phenethyl Isothiocyanate (PEITC) | Experimental | Drug: Phenethyl Isothiocyanate (PEITC)Starting dose 40 mg capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients with a histologically or cytologically confirmed lymphoproliferative disorder previously treated with fludarabine are eligible for this protocol.
- Patients must be 18 years of age or older.
- Patients must have a performance status of 0-2 (Zubrod scale).
- Patients must have adequate renal function (serum creatinine </= 2 mg/dL or creatinine clearance > 50 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the P.I. and consideration of appropriate dose adjustments.
- Patients must have adequate function (bilirubin </= 2.0 mg/dl; SGOT or SGPT </= 3X the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder [for bilirubin]). Patients with hepatic dysfunction due to organ infiltration by disease may be eligible after discussion with the P.I. and consideration of appropriate dose adjustments.
Key exclusion criteria (4 listed)
- Untreated or uncontrolled life-threatening infection (Grade 4 infection, i.e. septic shock, hypotension, acidosis, necrosis).
- Pregnancy or breastfeeding. Female patients of childbearing potential (including those <1 year postmenopausal) and male patients must agree to use contraception. A female of child bearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Chemotherapy and/or radiation therapy within 4 weeks of study enrollment.
- Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results.
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 |
|---|---|---|
| Phenethyl Isothiocyanate (PEITC)Starting dose 40 mg capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle. | Drug | Phenethyl Isothiocyanate (PEITC) |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 28 Day Cycle
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
- UT MD Anderson Cancer Center websiteLink 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.
Apostolia M. Tsimberidou, MD, PHD study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phenethyl Isothiocyanate (PEITC) in people with Leukemia and Lymphoproliferative Disorders, run by M.D. Anderson Cancer Center.
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 4 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: withdrawn, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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) (time frame: 28 Day Cycle). 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 15 Apr 2013.