LymphomaPhase 1NCT00049400
S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
A Phase 1 study testing BMS-247550 in people with Lymphoma and Small Intestine Cancer, run by SWOG Cancer Research Network at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- BMS-247550
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 23 sitesUnited States
- Study dates
- Oct 2003to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, 98225
Olympic Hematology and Oncology
Bremerton, Washington, 98310
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, 44131
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, 98273
University of California Davis Cancer Center
Sacramento, California, 95817
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Group Health Central Hospital
Seattle, Washington, 98104-1387
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98104
Harborview Medical Center
Seattle, Washington, 98104
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801-2028
Cleveland Clinic - Wooster
Wooster, Ohio, 44691
About this study
Official title: A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction
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.
Read the detailed description
OBJECTIVES:
- Determine the levels of hepatic impairment at which dose modifications of ixabepilone are required in patients with advanced solid tumors or lymphomas and varying levels of liver dysfunction.
- Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug in these patients.
- Determine the toxic effects of this drug at varying levels of hepatic dysfunction in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 but no more than 12 patients are treated at the recommended phase II dose.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 12-84 patients (6-12 for stratum 1; 2-18 for stratum 2; 2-24 for stratum 3; and 2-30 for stratum 4) will be accrued for this study within 12 months.
- Being tested
- BMS-247550
- Keywords
- unspecified adult solid tumor, protocol specific, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, intraocular lymphoma, primary central nervous system lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1, 2, or 3 follicular lymphoma, recurrent mantle cell lymphoma, small intestine lymphoma, stage IV adult diffuse large cell or mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma or Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Intraocular Lymphoma, Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease, Lymphoma, Large-Cell, Immunoblastic, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-247550Drug
BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Single-arm, dose-escalation of BMS-247550 Receives: Drug: BMS-247550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose defining
Measured: Treatment delays >2 weeks constitute a DLT
Secondary outcomes (2)
Progression
20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline.
Measured: 30 days after going off study
Symptomatic deterioration
Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Measured: 30 days after going off study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2003
- Primary completionSep 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Angela Davies, MD, Principal investigator, University of California, DavisChris H. Takimoto, MD, PhD, Principal investigator, Institute for Drug Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049400
- Sponsor's protocol ID
- S0355
- Other IDs
- U01CA076642, P30CA016087, S0355, U10CA032102
- Status last verified
- Apr 2015
- First submitted
- 12 Nov 2002
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction
- ClinicalTrials.gov ID
- NCT00049400
- Acronym / sponsor ID
- S0355
- Keywords
- unspecified adult solid tumor, protocol specific, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, intraocular lymphoma, primary central nervous system lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Determine the levels of hepatic impairment at which dose modifications of ixabepilone are required in patients with advanced solid tumors or lymphomas and varying levels of liver dysfunction.
- Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug in these patients.
- Determine the toxic effects of this drug at varying levels of hepatic dysfunction in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 but no more than 12 patients are treated at the recommended phase II dose.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 12-84 patients (6-12 for stratum 1; 2-18 for stratum 2; 2-24 for stratum 3; and 2-30 for stratum 4) will be accrued for this study within 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: BMS-247550Single-arm, dose-escalation of BMS-247550 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-247550BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle | Drug | treatment |
Primary outcome
dose defining
Time frame: Treatment delays >2 weeks constitute a DLT
2 secondary outcomes
Progression
Time frame: 30 days after going off study
Symptomatic deterioration
Time frame: 30 days after going off study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Results publicationTakimoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Davies, MD principal investigator
University of California, Davis
Chris H. Takimoto, MD, PhD principal investigator
Institute for Drug Development
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-247550 in people with Lymphoma and Small Intestine Cancer, run by SWOG Cancer Research Network at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose defining (time frame: Treatment delays >2 weeks constitute a DLT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00049400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.