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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00085 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000653877 | |||
| PHI 0453 | Other Identifier | Vanderbilt-Ingram Cancer Center | |
| 6816 | Other Identifier | CTEP | |
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| U01CA099177 | U.S. NIH Grant/Contract | View source |
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This phase I trial studies the side effects and best dose of SJG-136 in treating patients with solid tumors that are metastatic or cannot be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (SJG-136) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJG-136 | Drug | Given IV |
| |
| laboratory biomarker analysis |
| Measure | Description | Time Frame |
|---|---|---|
| MTD defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bivariate response variable (tumor response) evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor Puzanov | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| C423343 | 1,1'-((propane-1,3-diyl)dioxy)bis(7-methoxy-2-methylidene-1,2,3,10,11,11a-hexahydro-5H-pyrrolo(2,1-c)(1,4)benzodiazepin-5,11-dione) |
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| Other |
Correlative studies |
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| pharmacological study | Other | Correlative studies |
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