NCT00049400

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating patients with advanced solid tumors or lymphomas and liver dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for phase_1 lymphoma

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

November 12, 2002

Last Update Submit

April 1, 2015

Conditions

LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaintraocular lymphomaprimary central nervous system lymphomarecurrent adult diffuse large cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1, 2, or 3 follicular lymphomarecurrent mantle cell lymphomasmall intestine lymphomastage IV adult diffuse large cell or mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Burkitt lymphoma or Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult T-cell leukemia/lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage IV grade 1, 2, or 3 follicular lymphomastage IV mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of MALTnodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent adult Burkitt lymphomarecurrent adult lymphoblastic lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • dose defining

    Treatment delays >2 weeks constitute a DLT

Secondary Outcomes (2)

  • Progression

    30 days after going off study

  • Symptomatic deterioration

    30 days after going off study

Study Arms (1)

treatment

EXPERIMENTAL

Single-arm, dose-escalation of BMS-247550

Drug: BMS-247550

Interventions

BMS-247550DRUG

BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle

treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective * Pathological confirmation of diagnosis not required in patients with liver mass, raised alpha-fetoprotein levels (at least 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma * Any solid tumor or lymphoma tumor type eligible * Must have had thoracic and upper abdominal CT scan, including entire liver and adrenals, within 28 days before study entry * Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month * Prior whole brain or gamma knife radiotherapy required for known brain metastases * No unstable or untreated (non-irradiated) brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No active hemolysis Hepatic * See Disease Characteristics * Patients with biliary obstruction for which a shunt has been placed are allowed if shunt is in place for at least 10 days and liver function is stable * Abnormal liver function (bilirubin and SGOT) allowed regardless of cause (metastases or other causes) * No evidence of biliary sepsis Renal * Creatinine no greater than 1.5 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * No concurrent uncontrolled illness * No ongoing or active infection * No uncontrolled diarrhea * No peripheral neuropathy grade II or greater * No psychiatric illness or social situation that would preclude study compliance * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy for malignancy Chemotherapy * More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No other concurrent chemotherapy for malignancy Endocrine therapy * See Disease Characteristics * No concurrent oral contraceptives * No concurrent hormone therapy for malignancy * Concurrent luteinizing hormone-releasing hormone agonists allowed Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy for malignancy Surgery * More than 2 weeks since prior major surgery Other * Recovered from prior therapy * No concurrent medications that are known to be inhibitors of CYP3A4

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (23)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

St. Joseph Hospital Community Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98273, United States

Location

Group Health Central Hospital

Seattle, Washington, 98104-1387, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

Related Publications (1)

  • Takimoto CH, Liu PY, Lenz H, et al.: A phase I pharmacokinetic (PK) study of the epothilone B analogue, ixabepilone (BMS-247550) in patients (pts) with advanced malignancies and varying degrees of hepatic impairment. A SWOG Early Therapeutics Committee and NCI Organ Dysfunction Working Group Trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-2004, 2006.

    RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyIntraocular LymphomaLymphoma, Large B-Cell, DiffuseHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellLymphoma, Non-HodgkinBurkitt LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphadenopathyEye NeoplasmsNeoplasms by SiteLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Angela Davies, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Chris H. Takimoto, MD, PhD

    Institute for Drug Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

October 1, 2003

Primary Completion

September 1, 2006

Study Completion

December 1, 2007

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

US(23)