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BMS-247550 in Treating Patients With Advanced Cancers
This study is ongoing, but not recruiting participants.
First Received: September 11, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: University of Texas
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006221
  Purpose

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 Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: ixabepilone
Phase I

MedlinePlus related topics: Cancer Intestinal Cancer Lymphoma
Drug Information available for: Ixabepilone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006221

Locations
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
University of Texas
Investigators
Study Chair: Chris H. Takimoto, MD, PhD, FACP University of Texas
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068141, UTHSC-IDD-99-32, SACI-IDD-99-32, NCI-150
Study First Received: September 11, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006221     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
small intestine lymphoma
unspecified adult solid tumor, protocol specific
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
primary central nervous system lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
intraocular lymphoma

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Ileal Diseases
Follicular Lymphoma
Duodenal Neoplasms
Mycoses
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
B-cell Lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Gastrointestinal Diseases
Lymphoma, Follicular
Central Nervous System Lymphoma, Primary
Lymphoma, B-Cell, Marginal Zone
Sezary Syndrome
Mycosis Fungoides
Lymphoblastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Ileal Neoplasms
Cutaneous T-cell Lymphoma

Additional relevant MeSH terms:
Jejunal Neoplasms
Neoplasms by Histologic Type
Immunoproliferative Disorders
Digestive System Neoplasms
Immune System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Ileal Diseases
Intestinal Neoplasms
Duodenal Neoplasms
Lymphatic Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Gastrointestinal Neoplasms
Lymphoproliferative Disorders
Lymphoma
Duodenal Diseases

ClinicalTrials.gov processed this record on May 06, 2009