BMS-247550 in Treating Patients With Advanced Cancers
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ixabepilone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies |
| Enrollment: | 54 |
| Study Start Date: | November 2000 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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. |
Drug: ixabepilone |
Detailed Description:
OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies.
II. Determine the qualitative and quantitative toxic effects of this regimen in these patients.
III. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
IV. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and 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 | |
| Study Chair: | Chris H. Takimoto, MD, PhD, FACP | University of Texas Health Science Center at San Antonio |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006221 History of Changes |
| Other Study ID Numbers: | CDR0000068141, UTHSC-IDD-99-32, SACI-IDD-99-32, NCI-150 |
| Study First Received: | September 11, 2000 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 non-Hodgkin lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma intraocular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013