KRN5500 in Treating Patients With Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002923
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : April 25, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Patricia LoRusso, Barbara Ann Karmanos Cancer Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: KRN5500 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Evaluation of KRN5500 (NSC650426)
Study Start Date : May 1997
Actual Primary Completion Date : January 2000
Actual Study Completion Date : October 2000

Arm Intervention/treatment
Experimental: KRN5500 Drug: KRN5500

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 )
First Posted: May 26, 2004    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014

Keywords provided by Patricia LoRusso, Barbara Ann Karmanos Cancer Institute:
unspecified adult solid tumor, protocol specific