Expired Study
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New York, New York 10065


Purpose:

This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.


Study summary:

PRIMARY OBJECTIVES: I. To determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of SJG-136 in patients with an advanced solid tumor. SECONDARY OBJECTIVES: I. To determine preliminary efficacy data and evaluation of correlative markers of DNA damage and apoptosis in peripheral blood lymphocytes. OUTLINE: This is an open-label, dose-escalation study. Patients receive SJG-136 intravenously (IV) over 20 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 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.


Criteria:

Inclusion Criteria: - Histologically confirmed solid tumor - Advanced disease, defined as metastatic or unresectable disease - Measurable indicator lesions - Standard curative or palliative measures do not exist or are no longer effective - Previously treated CNS metastases allowed provided patient has completed local therapy AND corticosteroids have been discontinued for at least 4 weeks - No known leptomeningeal metastases - Performance status - ECOG 0-2 - Performance status - Karnofsky 60-100% - More than 3 months - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Bilirubin ≤ 1.0 mg/dL - AST and ALT ≤ 2.5 times upper limit of normal - Creatinine < 1.4 mg/dL - No congestive heart failure - No recent myocardial infarction - No unstable angina - No uncontrolled hypertension - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection - No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug - No other significant medical history, unstable medical condition, or unstable systemic disease that would preclude study participation - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and 8 weeks for UCN-01) - At least 4 weeks since prior radiotherapy - No prior radiotherapy to ≥ 25% of hematopoietic bone marrow - Recovered from all prior therapy - At least 4 weeks since prior investigational anticancer drugs - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients


NCT ID:

NCT00103220


Primary Contact:

Principal Investigator
Naiyer Rizvi
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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