A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Recommended phase 2 dose of SJG-136
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: SJG-136 (Drug)
Outcomes
Primary Outcomes
Recommended phase 2 dose of SJG-136
Time Frame: 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 Outcomes
No secondary outcomes reported