BMS-247550 in Treating Patients With Cancers That Have Not Responded to Previous Therapy
NCT ID: NCT00020371
Last Updated: 2024-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
INTERVENTIONAL
2000-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have cancers that have not responded to previous therapy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Treatments for Multiple Myeloma
NCT00001750
Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms
NCT02756572
Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
NCT00005958
Combination Chemotherapy With or Without Filgrastim in Treating Patients With Advanced Solid Tumors
NCT00008125
Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
NCT00002552
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
II. Evaluate the pharmacokinetics and pharmacodynamics of this drug in these patients.
III. Determine the occurrence of response in patients treated with this drug.
PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive BMS-247550 IV over 1 hour on days 1-5. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 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 at least 2 of 6 patients experience dose-limiting toxicity (DLT). Once the MTD is determined, additional patients are accrued to receive BMS-247550 at the recommended phase II dose.
If neutropenia is identified as the DLT, a second dose escalation is performed to identify the MTD of BMS-247550 with the addition of filgrastim (G-CSF) in cohorts as above. Patients receive fixed-dose G-CSF 72 hours after final BMS-247550 dose, and continuing until blood levels return to normal.
PROJECTED ACCRUAL:
A total of 45 patients will be accrued for this study within 12-18 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BMS-247550
filgrastim
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
--Disease Characteristics-- Histologically or cytologically confirmed neoplasm refractory to standard therapy or for which no standard therapy exists No CNS malignancy --Prior/Concurrent Therapy-- Biologic therapy: At least 4 months since prior myeloablative chemotherapy followed by bone marrow or stem cell rescue Chemotherapy: See Biologic therapy At least 4 weeks since prior chemotherapy (6 weeks for prior nitrosoureas or mitomycin) Endocrine therapy: At least 2 weeks since prior hormonal therapy for breast cancer At least 4 weeks since prior hormonal therapy for prostate cancer Radiotherapy: At least 4 weeks since prior radiotherapy No prior craniospinal irradiation, total body irradiation, or radiation to more than half of pelvis Surgery: Not specified Other: No other concurrent investigational drugs --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hepatic: SGOT/SGPT no greater than 2.5 times normal Bilirubin no greater than 1.5 times normal (no greater than 3 times normal if evidence of Gilbert's disease) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study No other nonmalignant systemic disease or serious medical illness No active uncontrolled infection HIV negative
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jame Abraham
Role: STUDY_CHAIR
National Cancer Institute (NCI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medicine Branch
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-00-C-0224
Identifier Type: -
Identifier Source: secondary_id
NCI-550
Identifier Type: -
Identifier Source: secondary_id
CDR0000068319
Identifier Type: -
Identifier Source: org_study_id
NCT00006317
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.