Third Phase I and Pharmacokinetic Study Of FB-642 Administered Orally To Patients With Advanced Solid Tumors
18 Years
N/A
Both
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Third Phase I and Pharmacokinetic Study Of FB-642 Administered Orally To Patients With Advanced Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose of carbendazim in patients with advanced
solid tumors or lymphoma. II. Determine the qualitative and quantitative toxic effects of
this drug in these patients. III. Determine the pharmacokinetics of this drug in these
patients. IV. Determine the recommended phase II dose of this drug. V. Determine any
antitumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral carbendazim 2-3
times daily 5 days a week for 3-4 weeks. Treatment repeats every 4 weeks in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of carbendazim until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 30-60 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor for which no
standard therapy exists or which has progressed or recurred after prior therapy OR
Lymphoma for which no further therapeutic options exist No hematological malignancies
(e.g., leukemia) No known brain or leptomeningeal disease unless previously treated with
radiotherapy, not currently treated with corticosteroid therapy, and no clinical symptoms
present
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at
least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2
mg/dL AST or ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if due
to tumor involvement) Alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no
greater than 2 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No
unstable atrial or ventricular arrhythmias that require control by medication No ischemic
event within the past 6 months Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception Abnormalities that would affect
absorption of study drug allowed at investigator's discretion No other severe disease or
psychiatric disorder that would preclude study No phenylketonuria No known
hypersensitivity reaction to artificial sweetener aspartame (e.g., Nutrasweet)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from
prior chemotherapy for cancer No other concurrent cytotoxic therapy Endocrine therapy: See
Disease Characteristics Radiotherapy: See Disease Characteristics Recovered from prior
radiotherapy for cancer Surgery: Recovered from prior surgery for cancer Prior
gastrointestinal surgery allowed
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Lee S. Rosen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068867
NCT ID:
NCT00023816
Start Date:
Completion Date:
Related Keywords:
- Lymphoma
- 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
- 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
- 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
- Neoplasms
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