Studying Fentanyl in Patients With Cancer | NCT00899951 | Trialant
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Studies Studying Fentanyl in Patients With Cancer NCT00899951 Show options Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 fentanyl citrate pharmacological study Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link P30CA006973 U.S. NIH Grant/Contract JHOC-J06129 JHOC-NA-00006329
Studying Fentanyl in Patients With Cancer
Pharmacokinetics of Continuous Infusion Fentanyl in Cancer Patients
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins OTHER
Overall Recruitment Status or Expanded Access Status Terminated
First Submission Date that Met QC Criteria May 9, 2009
Results First Submitted Date Not provided
Results First Submitted that Met QC Criteria Not provided
Results First Posted Date Not provided
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Apr 16, 2013
Responsible Party, by Official Title Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins OTHER
Name Class National Cancer Institute (NCI) NIH
Has Data Monitoring Committee (DMC) Yes
Pediatric Postmarket Surveillance of a Device Product Not provided
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.
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.
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 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 Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names Cohort 1 receiving fentaly citrate
Drug: fentanyl citrate Other: pharmacological study
Name Type Description Arm Group Labels Other Names fentanyl citrate Drug pharmacological study
Measure Description Time Frame Pharmacokinetics of fentanyl citrate two baseline samples, serial samples obtained at 0,4,8,24,48,72,96,168,240 hrs after discontinuing fentanyl
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
Accepts Healthy Volunteers No
Name Affiliation Role Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Principal Investigator
Facility Status City State ZIP Country Contacts Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21231-2410 United States
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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
stage III adult T-cell leukemia/lymphoma
stage III chronic lymphocytic leukemia
stage IV adult T-cell leukemia/lymphoma
stage IV chronic lymphocytic leukemia
T-cell large granular lymphocyte leukemia
recurrent adult Hodgkin lymphoma
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
cutaneous B-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
Waldenström macroglobulinemia
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult lymphoblastic lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
stage I adult Burkitt lymphoma
stage I adult diffuse large cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I mantle cell lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult grade III lymphomatoid granulomatosis
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
intraocular lymphoma
primary central nervous system non-Hodgkin lymphoma
primary central nervous system Hodgkin lymphoma
post-transplant lymphoproliferative disorder
chronic eosinophilic leukemia
chronic neutrophilic leukemia
primary myelofibrosis
essential thrombocythemia
polycythemia vera
extramedullary plasmacytoma
isolated plasmacytoma of bone
monoclonal gammopathy of undetermined significance
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
primary systemic amyloidosis
refractory multiple myeloma
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
myelodysplastic/myeloproliferative neoplasm, unclassifiable
pain
Intervention Model Description Not provided
No data available
No data is available for this block.
Other
ID Term D016543 Central Nervous System Neoplasms D009196 Myeloproliferative Disorders D007938 Leukemia D008223 Lymphoma D008232 Lymphoproliferative Disorders D009101 Multiple Myeloma D054219 Neoplasms, Plasma Cell D009190 Myelodysplastic Syndromes D054437 Myelodysplastic-Myeloproliferative Diseases D010146 Pain D011230 Precancerous Conditions D015465 Leukemia, Myeloid, Accelerated Phase D015456 Leukemia, Biphenotypic, Acute D000013 Congenital Abnormalities D054438 Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative D001752 Blast Crisis D015477 Leukemia, Myelomonocytic, Chronic D015466 Leukemia, Myeloid, Chronic-Phase D007946 Leukemia, Mast-Cell D015463 Leukemia, Prolymphocytic D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma D015470 Leukemia, Myeloid, Acute D054218 Precursor T-Cell Lymphoblastic Leukemia-Lymphoma D015451 Leukemia, Lymphocytic, Chronic, B-Cell D007943 Leukemia, Hairy Cell D054066 Leukemia, Large Granular Lymphocytic D006689 Hodgkin Disease D017728 Lymphoma, Large-Cell, Anaplastic D007119 Immunoblastic Lymphadenopathy D016410 Lymphoma, T-Cell, Cutaneous D009182 Mycosis Fungoides D012751 Sezary Syndrome D054391 Lymphoma, Extranodal NK-T-Cell D008258 Waldenstrom Macroglobulinemia D018442 Lymphoma, B-Cell, Marginal Zone D002051 Burkitt Lymphoma D016403 Lymphoma, Large B-Cell, Diffuse D008228 Lymphoma, Non-Hodgkin D016400 Lymphoma, Large-Cell, Immunoblastic D008224 Lymphoma, Follicular D020522 Lymphoma, Mantle-Cell D064090 Intraocular Lymphoma C580364 Pdgfra-Associated Chronic Eosinophilic Leukemia D015467 Leukemia, Neutrophilic, Chronic D055728 Primary Myelofibrosis D013920 Thrombocythemia, Essential D011087 Polycythemia Vera D008998 Monoclonal Gammopathy of Undetermined Significance D000075363 Immunoglobulin Light-chain Amyloidosis
ID Term D009423 Nervous System Neoplasms D009371 Neoplasms by Site D009369 Neoplasms D009422 Nervous System Diseases D001855 Bone Marrow Diseases D006402 Hematologic Diseases D006425 Hemic and Lymphatic Diseases D009370 Neoplasms by Histologic Type D008206 Lymphatic Diseases D007160 Immunoproliferative Disorders D007154 Immune System Diseases D020141 Hemostatic Disorders D014652 Vascular Diseases D002318 Cardiovascular Diseases D010265 Paraproteinemias D001796 Blood Protein Disorders D006474 Hemorrhagic Disorders D009461 Neurologic Manifestations D012816 Signs and Symptoms D013568 Pathological Conditions, Signs and Symptoms D015464 Leukemia, Myelogenous, Chronic, BCR-ABL Positive D007951 Leukemia, Myeloid D002908 Chronic Disease D020969 Disease Attributes D010335 Pathologic Processes D007945 Leukemia, Lymphoid D009358 Congenital, Hereditary, and Neonatal Diseases and Abnormalities D002471 Cell Transformation, Neoplastic D063646 Carcinogenesis D009385 Neoplastic Processes D034721 Mastocytosis, Systemic D008415 Mastocytosis D000090362 Mast Cell Activation Disorders D015448 Leukemia, B-Cell D015458 Leukemia, T-Cell D016399 Lymphoma, T-Cell D000072281 Lymphadenopathy D016393 Lymphoma, B-Cell D020031 Epstein-Barr Virus Infections D006566 Herpesviridae Infections D004266 DNA Virus Infections D014777 Virus Diseases D007239 Infections D014412 Tumor Virus Infections D005134 Eye Neoplasms D001778 Blood Coagulation Disorders D013922 Thrombocytosis D001791 Blood Platelet Disorders D019046 Bone Marrow Neoplasms D019337 Hematologic Neoplasms D006942 Hypergammaglobulinemia D000686 Amyloidosis D057165 Proteostasis Deficiencies D008659 Metabolic Diseases D009750 Nutritional and Metabolic Diseases
ID Term D010880 Piperidines D006573 Heterocyclic Compounds, 1-Ring D006571 Heterocyclic Compounds