A Phase 1 interventional study of KRN5500 in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Barbara Ann Karmanos Cancer Institute. Completed at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2014-04-25.
Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 1, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to evaluate the effectiveness of KRN5500 in treating patients with metastatic solid tumors.
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.
Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Drug: KRN5500
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Barbara Ann Karmanos Cancer Institute