Clinical trial · Interventional
SJG-136 in Treating Patients With Advanced Solid Tumors
A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor
NCT00103220CI-TRIAL-00012938completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SJG-136 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SJG-136)
- description
- 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.
- interventionNames
- Drug: SJG-136
Primary outcomes (1)
- measure
- Recommended phase 2 dose of SJG-136
- timeFrame
- Day 28
- description
- Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.