SJG-136 in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery
Unspecified Adult Solid Tumor, Protocol Specific
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation Study of Daily x 3 Intravenous SJG-136 in Patients With Advanced Solid Tumors|
- MTD defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- Bivariate response variable (tumor response) evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: Treatment (SJG-136)
Patients receive SJG-136 IV over 20 minutes once daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Given IVOther: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studies
I. Determine the maximum tolerated dose and recommended phase II dose of SJG-136 in patients with metastatic or unresectable solid tumors.
II. Determine the safety and dose-limiting toxic effects of this drug in these patients.
III. Determine, preliminarily, the efficacy of this drug in these patients.
I. Determine the pharmacokinetic parameters of this drug and its metabolites in these patients.
II. Correlate pharmacokinetic parameters with clinical effects of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive SJG-136 intravenously (IV) over 20 minutes once daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed up for 30 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121290
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Igor Puzanov||Vanderbilt-Ingram Cancer Center|