- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00899951
Studying Fentanyl in Patients With Cancer
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.
Study Overview
Status
Conditions
- Pain
- Lymphoma
- Myelodysplastic Syndromes
- Leukemia
- Chronic Myeloproliferative Disorders
- Brain and Central Nervous System Tumors
- Unspecified Adult Solid Tumor, Protocol Specific
- Multiple Myeloma and Plasma Cell Neoplasm
- Precancerous Condition
- Lymphoproliferative Disorder
- Myelodysplastic/Myeloproliferative Neoplasms
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort 1
receiving fentaly citrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stuart A. Grossman, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified adult solid tumor, protocol specific
- pain
- primary myelofibrosis
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage 0 chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- 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)
- secondary acute myeloid leukemia
- chronic phase chronic myelogenous leukemia
- primary systemic amyloidosis
- recurrent adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage I multiple myeloma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- primary central nervous system non-Hodgkin lymphoma
- refractory chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- intraocular lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- post-transplant lymphoproliferative disorder
- cutaneous B-cell non-Hodgkin lymphoma
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- polycythemia vera
- essential thrombocythemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- Waldenström macroglobulinemia
- monoclonal gammopathy of undetermined significance
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- stage I mantle cell lymphoma
- isolated plasmacytoma of bone
- extramedullary plasmacytoma
- acute undifferentiated leukemia
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I adult Burkitt lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- atypical chronic myeloid leukemia, BCR-ABL1 negative
- meningeal chronic myelogenous leukemia
- contiguous stage II grade 3 follicular lymphoma
- stage I grade 3 follicular lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage II mycosis fungoides/Sezary syndrome
- mast cell leukemia
- progressive hairy cell leukemia, initial treatment
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- T-cell large granular lymphocyte leukemia
- contiguous stage II adult lymphoblastic lymphoma
- stage I adult lymphoblastic lymphoma
- primary central nervous system Hodgkin lymphoma
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Disease
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Plasmacytoma
- Lymphoproliferative Disorders
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Precancerous Conditions
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- J06129 CDR0000600337
- P30CA006973 (U.S. NIH Grant/Contract)
- JHOC-J06129
- JHOC-NA-00006329
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
Clinical Trials on pharmacological study
-
National Cancer Institute (NCI)TerminatedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma and other conditionsUnited States
-
Universitätsmedizin MannheimHeidelberg UniversityUnknownLung Cancer | Brain and Central Nervous System TumorsGermany
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); Peloton Therapeutics, Inc.CompletedRecurrent GlioblastomaUnited States
-
National Cancer Institute (NCI)TerminatedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Recurrent Childhood Soft Tissue Sarcoma | Recurrent Childhood Brain Stem Glioma | Recurrent Childhood Visual Pathway Glioma | Childhood Central Nervous System Germ Cell Tumor | Childhood Central Nervous System Choriocarcinoma | Childhood Central... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary SyndromeUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Male Breast Cancer | Stage IV Breast Cancer | Stage IV Ovarian Epithelial Cancer | Stage IV Renal Cell Cancer | Recurrent Renal Cell Cancer | Recurrent Breast Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage...United States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMyeloid Proliferations Associated With Down SyndromeUnited States, Canada, Australia, Puerto Rico