A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies
18 Years
N/A
Both
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies
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.
Inclusion 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:
- 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Chris H. Takimoto, MD, PhD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
University of Texas Health Science Center at San Antonio
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068141
NCT ID:
NCT00006221
Start Date:
November 2000
Completion Date:
Related Keywords:
- Lymphoma
- Small Intestine Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- 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
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Intestinal Neoplasms
Name | Location |
|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Cancer Therapy and Research Center | San Antonio, Texas 78229 |
