Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Studying Fentanyl in Patients With Cancer

This study has been terminated.
(poor accrual)
Sponsor:
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
History of Changes
  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:

Genetic and Rare Diseases Information Center resources: AL Amyloidosis Acute Lymphoblastic Leukemia Acute Monoblastic Leukemia Acute Myeloblastic Leukemia Type 5 Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Non Lymphoblastic Leukemia Anaplastic Large Cell Lymphoma Anaplastic Plasmacytoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Angioimmunoblastic T-cell Lymphoma B-cell Lymphomas Burkitt Lymphoma Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Chronic Myeloproliferative Disorders Chronic Neutrophilic Leukemia Cutaneous T-cell Lymphoma Essential Thrombocythemia Follicular Lymphoma Hairy Cell Leukemia Hodgkin Lymphoma Hypereosinophilic Syndrome Large Granular Lymphocyte Leukemia Leukemia, B-cell, Chronic Leukemia, Myeloid Leukemia, T-cell, Chronic Lymphoblastic Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphomatoid Granulomatosis Lymphosarcoma Mantle Cell Lymphoma Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic/myeloproliferative Disease Myelofibrosis Plasmablastic Lymphoma Polycythemia Vera Sezary Syndrome Small Non-cleaved Cell Lymphoma Squamous Cell Carcinoma of the Head and Neck Systemic Mastocytosis Waldenstrom Macroglobulinemia
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 ] [ Designated as safety issue: No ]
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
Genders Eligible for Study:   Both
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

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

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00899951     History of Changes
Other Study ID Numbers: J06129 CDR0000600337, P30CA006973, JHOC-J06129, JHOC-NA-00006329
Study First Received: May 9, 2009
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

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:
Central Nervous System Neoplasms
Disease
Lymphoproliferative Disorders
Multiple Myeloma
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms, Plasma Cell
Nervous System Neoplasms
Plasmacytoma
Precancerous Conditions
Preleukemia
Blood Protein Disorders
Bone Marrow Diseases
 Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Paraproteinemias
Pathologic Processes
Vascular Diseases
Fentanyl
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on February 27, 2015