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BMS-247550 in Treating Patients With Cancers That Have Not Responded to Previous Therapy

Primary Purpose

Unspecified Adult Solid Tumor, Protocol Specific, Neutropenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-247550
filgrastim
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unspecified Adult Solid Tumor, Protocol Specific focused on measuring adult solid tumor, bone marrow suppression, cancer, cancer-related problem/condition, neutropenia, solid tumor, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)

PROTOCOL ENTRY 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

Sites / Locations

  • Medicine Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 2, 2007
Last Updated
April 27, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00020371
Brief Title
BMS-247550 in Treating Patients With Cancers That Have Not Responded to Previous Therapy
Official Title
Phase I Study of BMS-247550 in Patients With Refractory Neoplasms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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 cancers that have not responded to previous therapy.
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose, dose-limiting toxic effects, and recommended phase II dose of BMS-247550 in patients with refractory neoplasms. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Adult Solid Tumor, Protocol Specific, Neutropenia
Keywords
adult solid tumor, bone marrow suppression, cancer, cancer-related problem/condition, neutropenia, solid tumor, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BMS-247550
Intervention Type
Drug
Intervention Name(s)
filgrastim

10. Eligibility

Minimum Age & Unit of Time
18 Years
Eligibility Criteria
PROTOCOL ENTRY 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jame Abraham
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Medicine Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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BMS-247550 in Treating Patients With Cancers That Have Not Responded to Previous Therapy

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