BMS-247550 in Treating Patients With Advanced Cancers
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ClinicalTrials.gov Identifier: NCT00006221 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : February 11, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific | Drug: ixabepilone | Phase 1 |
OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies.
II. Determine the qualitative and quantitative toxic effects of this regimen in these patients.
III. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
IV. Determine the antitumor effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to prior therapy (heavily pretreated vs minimally pretreated).
Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course.
Patients are followed within 1 month.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies |
Study Start Date : | November 2000 |
Actual Primary Completion Date : | June 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I
Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course. |
Drug: ixabepilone |

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant solid tumor or lymphoma for which no other potentially curative therapeutic option exists or demonstrates increased survival (considering tumor type, stage, and number of prior regimens)
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No symptomatic brain metastases requiring dexamethasone
- No progression or cerebral edema on CT scan or MRI within the past 4 weeks
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Hemoglobin at least 8.5 g/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No atrial or ventricular arrhythmias requiring medication
- No ischemic event within the past 6 months
Other:
- No pre-existing peripheral neuropathy greater than grade 1
- No other serious medical illness or active infection that would preclude study participation
- No dementia, psychiatric illness, or other alteration in mental status that would preclude study compliance
- No other active malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- No history of allergy or hypersensitivity reaction to paclitaxel or other Cremophor EL-containing compound
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study completion
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- At least 4 weeks since prior anticancer hormonal therapy and recovered
- No concurrent hormonal therapy except LHRH agonists for non-castrated prostate cancer, contraceptives, hormone replacement therapy (e.g., conjugated estrogens), or megestrol as an appetite stimulant
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
- Concurrent palliative radiotherapy to limited sites allowed
Surgery:
- At least 4 weeks since prior surgery and recovered
Other:
- At least 30 days since prior investigational agents and recovered
- No other concurrent experimental medications
- No concurrent antiretroviral (HAART) therapy for HIV-positive patients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006221
United States, Texas | |
Cancer Therapy and Research Center | |
San Antonio, Texas, United States, 78229 | |
Veterans Affairs Medical Center - San Antonio (Murphy) | |
San Antonio, Texas, United States, 78229 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-7811 |
Study Chair: | Chris H. Takimoto, MD, PhD, FACP | The University of Texas Health Science Center at San Antonio |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006221 |
Other Study ID Numbers: |
CDR0000068141 UTHSC-IDD-99-32 SACI-IDD-99-32 NCI-150 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | February 11, 2013 |
Last Verified: | July 2004 |
stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma small intestine lymphoma unspecified adult solid tumor, protocol specific stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma primary central nervous system non-Hodgkin lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma intraocular lymphoma |
Lymphoma Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |