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KRN5500 in Treating Patients With Metastatic Solid Tumors

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Patricia LoRusso, Barbara Ann Karmanos Cancer Institute Identifier:
First received: November 1, 1999
Last updated: April 24, 2014
Last verified: April 2014

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.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: KRN5500 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Evaluation of KRN5500 (NSC650426)

Further study details as provided by Patricia LoRusso, Barbara Ann Karmanos Cancer Institute:

Estimated Enrollment: 27
Study Start Date: May 1997
Study Completion Date: October 2000
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KRN5500 Drug: KRN5500

Detailed Description:

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.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00002923

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute
  More Information

Responsible Party: Patricia LoRusso, Principal Investigator, Barbara Ann Karmanos Cancer Institute Identifier: NCT00002923     History of Changes
Other Study ID Numbers: CDR0000065328
U01CA062487 ( U.S. NIH Grant/Contract )
P30CA022453 ( U.S. NIH Grant/Contract )
Study First Received: November 1, 1999
Last Updated: April 24, 2014

Keywords provided by Patricia LoRusso, Barbara Ann Karmanos Cancer Institute:
unspecified adult solid tumor, protocol specific processed this record on July 19, 2017