SJG-136 in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00103220
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
-
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
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Performance status - ECOG 0-2
-
Performance status - Karnofsky 60-100%
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More than 3 months
-
WBC ≥ 3,000/mm^3
-
Absolute neutrophil count ≥ 1,500/mm^3
-
Platelet count ≥ 100,000/mm^3
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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)
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At least 4 weeks since prior radiotherapy
-
No prior radiotherapy to ≥ 25% of hematopoietic bone marrow
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Recovered from all prior therapy
-
At least 4 weeks since prior investigational anticancer drugs
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No other concurrent investigational agents
-
No concurrent combination antiretroviral therapy for HIV-positive patients
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (SJG-136) SJG-136 Patients receive SJG-136 IV over 20 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Recommended phase 2 dose of SJG-136 Day 28 Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States