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Home > "K" Clinical Trials Conditions > KRN5500 in Treating Patients With Solid Tumors  KRN5500 in Treating Patients With Solid Tumors
KRN5500 in Treating Patients With Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of KRN5500 in treating patients who have solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxic effects of KRN5500 in patients with solid tumors. - Assess the safety of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Describe the antitumor activity of this drug in these patients. - Determine pharmacodynamic relationships for the pharmacological effect of this drug upon surrogate markers of activity and toxicity in these patients. - Compare the toxicity profiles for the 1-hour and 72-hour infusion administration schedules of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive KRN5500 IV over 24-72 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive KRN5500 at the starting dose over escalating infusion durations. After the longest duration of infusion time is safely reached, cohorts of 3-6 patients receive escalating doses of KRN5500 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with KRN5500 at the recommended phase II dose. Patients are followed every 4 weeks until resolution of all toxicity. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Metastatic or inoperable malignancy for which there is no known curative or survival-prolonging palliative therapy or that has failed all such therapies - No leukemia or primary CNS tumors - No active brain metastases, including: - No evidence of cerebral edema by CT scan or MRI - No progression from prior imaging study - No requirement for steroids - No related clinical symptoms PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 2 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No uncontrolled or significant cardiac disease - No myocardial infarction within the past 6 months - No significant congestive heart failure - No prior clinically significant atrial or ventricular arrhythmia - No prior second or third degree heart block - No evidence of acute ischemia or prolonged QTc interval (greater than 450 ms) on electrocardiogram Pulmonary: - No uncontrolled or significant pulmonary disease Other: - No serious uncontrolled medical disorder that would preclude study participation - No active infection - No psychiatric illness that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: - See Disease Characteristics Radiotherapy: - At least 3 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - At least 2 weeks since prior major surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephEder, Study Chair, Dana-Farber/Harvard Cancer Center
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Anna Berkenblit 617-667-4283
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Joseph Eder 617-632-5588
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Glenn Mills 318-675-7639
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Jeffrey Clark 617-726-8743
Additional Information:
Study ID Numbers: CDR0000068666; DFCI-00102,NCI-1653
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017238
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
2. Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
3. BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
4. BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
5. 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
KRN5500 in Treating Patients With Solid Tumors
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