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Studying Fentanyl in Patients With Cancer
This study has been terminated.
(poor accrual)
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00899951
First received: May 9, 2009
Last updated: April 16, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
| Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Pain Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | Drug: fentanyl citrate Other: pharmacological study |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple myeloma
Genetic and Rare Diseases Information Center resources:
Multiple Myeloma
Anaplastic Plasmacytoma
Lymphosarcoma
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
Myelodysplastic Syndromes
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
Myelofibrosis
B-cell Lymphoma
Chronic Myeloproliferative Disorders
Hodgkin Lymphoma
Waldenstrom Macroglobulinemia
Chronic Myelomonocytic Leukemia
Cutaneous T-cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Lymphoma, Large-cell
Lymphoblastic Lymphoma
Polycythemia Vera
Essential Thrombocythemia
Burkitt Lymphoma
AL Amyloidosis
Marginal Zone Lymphoma
Leukemia, T-cell, Chronic
Adult T-cell Leukemia/lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Angioimmunoblastic Lymphadenopathy With Dysproteinemia
Mycosis Fungoides
Extranodal Nasal NK/T Cell Lymphoma
Sezary Syndrome
Lymphomatoid Granulomatosis
Plasmablastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Hairy Cell Leukemia
Monoclonal Gammopathy of Undetermined Significance
Large Granular Lymphocyte Leukemia
Aggressive NK Cell Leukemia
Myelodysplastic/myeloproliferative Disease
Chronic Neutrophilic Leukemia
U.S. FDA Resources
Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 2 |
| Study Start Date: | October 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cohort 1
receiving fentaly citrate
|
Drug: fentanyl citrate Other: pharmacological study |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
cancer pts
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899951
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899951
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Stuart A. Grossman, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00899951 History of Changes |
| Other Study ID Numbers: |
J06129 CDR0000600337 P30CA006973 ( US NIH Grant/Contract Award Number ) JHOC-J06129 JHOC-NA-00006329 |
| Study First Received: | May 9, 2009 |
| Last Updated: | April 16, 2013 |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
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 recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage 0 chronic lymphocytic leukemia stage I adult T-cell leukemia/lymphoma stage I chronic lymphocytic leukemia stage II adult T-cell leukemia/lymphoma stage II chronic lymphocytic leukemia |
Additional relevant MeSH terms:
|
Lymphoma Disease Syndrome Leukemia Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Nervous System Neoplasms Central Nervous System Neoplasms Myeloproliferative Disorders Plasmacytoma Lymphoproliferative Disorders Myelodysplastic-Myeloproliferative Diseases |
Precancerous Conditions Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Neoplasms by Site |
ClinicalTrials.gov processed this record on June 22, 2017