RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have malignant solid tumors or lymphoma.

Condition	Treatment or Intervention	Phase
adult solid tumor Leukemia Lymphoma small intestine cancer	Drug: ixabepilone  Procedure: chemotherapy	Phase I

Further Study Details: 

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.

PROJECTED ACCRUAL: Approximately 54 patients will be accrued for this study within 1 year.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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:

• See Disease Characteristics
• 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

Texas
      Cancer Therapy and Research Center, San Antonio,  Texas,  78229,  United States; Recruiting
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States; Recruiting
      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78229,  United States; Recruiting

Study chairs or principal investigators

Eric Keith Rowinsky, MD,  Study Chair,  Cancer Therapy and Research Center   

Study ID Numbers:  CDR0000068141; UTHSC-IDD-99-32; SACI-IDD-99-32; NCI-150; NCT00006221
Record last reviewed:  June 2004
Last Updated:  December 6, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006221
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08