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KRN5500 in Treating Patients With Metastatic Solid Tumors



KRN5500 in Treating Patients With Metastatic Solid Tumors

For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Barbara Ann Karmanos Cancer Institute
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PatriciaLoRusso,  Study Chair,  Barbara Ann Karmanos Cancer Institute

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201
United States
 


Additional Information:
Study ID Numbers:  CDR0000065328;  WSU-1294,NCI-T96-0004
Study Start Date: May 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002923

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. S-3304 in Treating Patients With Advanced Solid Tumors

2. Chemotherapy and Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors

3. KRN5500 in Treating Patients With Solid Tumors

4. CCI-779 in Treating Patients With Advanced Solid Tumors

5. Irinotecan in Treating Patients With Advanced Solid Tumors

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