Brain and Central Nervous System TumorsNCT00899951
Studying Fentanyl in Patients With Cancer
An observational study of Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Studying blood samples from cancer patients undergoing pain treatment in the laboratory may help doctors learn more about how pain drugs work in the body. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at fentanyl in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia
- What is being tested?
- fentanyl citrate and pharmacological study
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2009
- Phase
- Observational
- 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
Study population: cancer pts
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Inpatient at the Johns Hopkins Hospital Cancer Center undergoing pain treatment with continuous infusion fentanyl citrate for ≥ 5 days
PATIENT CHARACTERISTICS:
- Willing to change to an alternative opioid
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 72 hours since transdermal fentanyl citrate administration
- At least 12 hours since transmucosal fentanyl citrate administration
- No known requirement for continued opioid therapy with any fentanyl citrate products after discontinuation of fentanyl citrate therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients
RATIONALE: Studying blood samples from cancer patients undergoing pain treatment in the laboratory may help doctors learn more about how pain drugs work in the body. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at fentanyl in patients with cancer.
Read the detailed description
OBJECTIVES:
- To describe the pharmacokinetics of prolonged intravenous infusions of fentanyl citrate in adult patients with cancer.
OUTLINE: Patients undergo blood sample collection before and after discontinuation of fentanyl citrate therapy (10 days total). Pharmacokinetic analysis is performed on the samples.
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- Being tested
- fentanyl citrate, pharmacological study
- Keywords
- unspecified adult solid tumor, protocol specific, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), atypical chronic myeloid leukemia, BCR-ABL1 negative, blastic phase chronic myelogenous leukemia, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, mast cell leukemia, meningeal chronic myelogenous leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia
- Medical subject headings
- Central Nervous System Neoplasms, Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl citrateDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | receiving fentaly citrate Receives: Drug: fentanyl citrate; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of fentanyl citrate
Measured: two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stuart A. Grossman, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899951
- Sponsor's protocol ID
- J06129 CDR0000600337
- Other IDs
- P30CA006973, JHOC-J06129, JHOC-NA-00006329
- Status last verified
- Apr 2013
- First submitted
- 9 May 2009
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients
- ClinicalTrials.gov ID
- NCT00899951
- Acronym / sponsor ID
- J06129 CDR0000600337
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- unspecified adult solid tumor, protocol specific, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 12 May 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.
RATIONALE: Studying blood samples from cancer patients undergoing pain treatment in the laboratory may help doctors learn more about how pain drugs work in the body. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at fentanyl in patients with cancer.
Detailed description
OBJECTIVES:
- To describe the pharmacokinetics of prolonged intravenous infusions of fentanyl citrate in adult patients with cancer.
OUTLINE: Patients undergo blood sample collection before and after discontinuation of fentanyl citrate therapy (10 days total). Pharmacokinetic analysis is performed on the samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: fentanyl citrate, Other: pharmacological studyreceiving fentaly citrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cancer pts
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 |
|---|---|---|
| fentanyl citrate | Drug | Cohort 1 |
| pharmacological study | Other | Cohort 1 |
Primary outcome
Pharmacokinetics of fentanyl citrate
Time frame: two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl
Results and safety
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
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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.
Stuart A. Grossman, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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?
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 18 Apr 2013. 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.
Are results available for this study?
The study was stopped early (reason given: poor accrual). 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?
Pharmacokinetics of fentanyl citrate (time frame: two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl). 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 18 Apr 2013.