A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma (NCT00199342) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma
Stopped: Occurrence of 2 dose-limiting toxicities at the initial dose level (60 mg/m2) in Part I.
United States5 participantsStarted 2004-11
Plain-language summary
This is a dose escalating cohort study to determine the maximum tolerated dose (MTD) of KW-2871 (in dose cohorts of 60, 80, and 100 mg/m2) when administered with a specified premedication regimen (ranitidine, diphenhydramine, and dexamethasone). KW-2871 will be administered at 14-day intervals.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients \> 18 years of age
✓. Patients with documented Stage IV melanoma (histologically- or cytologically-proven, as per AJCC criteria) that is not currently amenable to surgical resection (due to either medical contraindication or non-resectability of tumor)
✓. Patients may have measurable or non-measurable disease, in accordance with the RECIST criteria.
✓. Failure of at least one, but no more than 3, standard treatment regimen(s) for metastatic disease
✓. Patients must have adequate end-organ function including:
✓. Hemoglobin \> 9.0 g/dL
✓. ANC \> 1500/mm3
✓. Platelet count \> 100,000/ mm3
Exclusion criteria
✕. Women who are pregnant or lactating and women of childbearing potential and fertile men not agreeing to a medically effective method of contraception. Women of childbearing potential will be informed as to the potential risk of procreation while participating in this study and will be advised that they must use effective contraception (e.g. oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) during the treatment period and for a period of 3 months following the completion of dosing.
✕. Patients with significant cardiovascular disease as defined by The New York Heart Association Classification (Class III or higher)
What they're measuring
1
To determine the MTD and a recommended Phase II dose of KW-2871 administered with a specified premedication regimen (rantidine, diphenhydramine, and dexamethasone) in patients with Stage IV melanoma.
✕. Patients with symptomatic or known brain metastases unless patient has undergone radiotherapy (or treatment with gamma knife) or resection of an isolated lesion and maintenance steroids are not required
✕. Patients with a history of another malignancy within the last 2 years with the exception of:
✕. Patients with any uncontrolled infection or other intercurrent illness
✕. Patients with any history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of an underlying disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
✕. Patients with known HIV infection
✕. Patients with inadequate recovery from any prior surgical procedure