Unspecified Adult Solid Tumor, Protocol Specific
Conditions
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.
Interventions
DRUGSJG-136
Given IV
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed