BMS-247550 in Treating Patients With Advanced Cancers

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00006221

Collaborator

(none)

Enrollment

Locations

Arm

Patients Per Site

Study Details

Study Description

Brief Summary

Phase I trial to study the effectiveness of BMS-247550 in treating patients who have malignant solid tumors or lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific	Drug: ixabepilone	Phase 1

Detailed Description

OBJECTIVES:

Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies.
Determine the qualitative and quantitative toxic effects of this regimen in these patients.
Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
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 Design

Study Type:

Interventional

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 :

Nov 1, 2000

Actual Primary Completion Date :

Jun 1, 2005

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
2	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78229
3	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7811