Clinical trial · Interventional
BMS-247550 in Treating Patients With Advanced Cancers
A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies
NCT00006221CI-TRIAL-00009395completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: ixabepilone
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.