SJG-136 in Treating Patients With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
- To determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of SJG-136 in patients with an advanced solid tumor.
SECONDARY OBJECTIVES:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (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. |
Drug: SJG-136
Given IV
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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
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No known leptomeningeal metastases
-
Performance status - ECOG 0-2
-
Performance status - Karnofsky 60-100%
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More than 3 months
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WBC ≥ 3,000/mm^3
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Absolute neutrophil count ≥ 1,500/mm^3
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Platelet count ≥ 100,000/mm^3
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Bilirubin ≤ 1.0 mg/dL
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AST and ALT ≤ 2.5 times upper limit of normal
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Creatinine < 1.4 mg/dL
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No congestive heart failure
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No recent myocardial infarction
-
No unstable angina
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No uncontrolled hypertension
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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No active infection
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No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
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No other significant medical history, unstable medical condition, or unstable systemic disease that would preclude study participation
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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
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No prior radiotherapy to ≥ 25% of hematopoietic bone marrow
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Recovered from all prior therapy
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At least 4 weeks since prior investigational anticancer drugs
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No other concurrent investigational agents
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No concurrent combination antiretroviral therapy for HIV-positive patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Naiyer Rizvi, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2012-01462
- NCI-2012-01462
- MSKCC-04076
- CDR0000409581
- NCI-6818
- 04-076
- 6818
- U01CA069856