Phase I Evaluation of KRN5500 (NSC650426)
KRN5500
Treatment Study
Summary
Study start date: May 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of KRN5500 in patients with solid malignant tumors. II. Characterize the clinical pharmacokinetics of KRN5500 in this patient population. III. Initiate the preliminary evaluation of antitumor activity of KRN5500 in these patients. IV. Determine the recommended Phase II dose of KRN5500. OUTLINE: This is a dose escalation study. Patients receive KRN5500 IV over 1 hour on days 1-3. Courses repeat every 21 days. Patients with stable disease and partial or complete remission continue treatment for 6 months beyond complete remission. Cohorts of 3 to 6 patients receive escalating doses of KRN5500. The maximum tolerated dose is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study over 9-12 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.27 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 15 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
DISEASE CHARACTERISTICS: Histologically proven solid malignant tumors with convincing clinical, radiographic or isotopic evidence of dissemination Biopsy proof required in all doubtful cases Must not be eligible for any known regimens or treatments of higher potential efficacy PATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 Life Expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of acute myocardial infarction within the past 6 months No clinically significant cardiac arrhythmias No New York Heart Association class III or IV disease Other: HIV negative No GI bleeding or bleeding tendency Not pregnant or nursing Effective contraception required for fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Must have recovered from prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered At least 6 weeks since prior nitrosourea or mitomycin Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Barbara Ann Karmanos Cancer Institute
Detroit, United StatesOpen Barbara Ann Karmanos Cancer Institute in Google Maps