Phase I Evaluation of KRN5500 (NSC650426)
15 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Evaluation of KRN5500 (NSC650426)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Patricia M. LoRusso, DO
Investigator Role:
Study Chair
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000065328
NCT ID:
NCT00002923
Start Date:
May 1997
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
