SJG-136 in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: SJG-136


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (SJG-136)<br>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<br>* Given IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recommended phase 2 dose of SJG-136 | Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose. | Day 28 |