Clinical trial · Interventional
Safingol and Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
An Open-Labeled, Non-Randomized Phase I Study of Safingol Administered With Cisplatin in Patients With Advanced Solid Tumors
NCT00084812CI-TRIAL-00009798completedPhase 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)
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Safingol may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of safingol when given with cisplatin in treating patients with locally advanced or metastatic solid tumors.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| safingol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Safingol and Cisplatin
- description
- Patients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1. Courses repeat every 21 days\* in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only; course 1 is 28 days in duration. Cohorts of 3-6 patients receive escalating doses of safingol 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. Once the MTD is determined, 10 additional patients are treated at that dose level.
- interventionNames
- Drug: cisplatin
- Drug: safingol
Primary outcomes (1)
- measure
- Recommended phase II dose as assessed by NCI toxicity scale during 3-4 weeks of treatment
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Locally advanced or metastatic disease * Refractory to standard therapy OR not amenable to standard therapy * No known CNS metastasis or CNS primary PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 12 weeks Hematopoietic * Neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * WBC count ≥ 3,500/mm\^3 * Hemoglobin ≥ 9.5 g/dL * Haptoglobin ≥ 30 mg/dL * No concurrent hemolysis or history of non-drug-induced hemolysis (e.g., spherocytosis) Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL * PT and PTT normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No cardiac arrhythmias * No congestive heart failure * No myocardial infarction within the past 6 months Other * Not pregnant * Negative pregnancy test * No nursing during and for at least 2 months after study participation * Fertile patients must use effective contraception during and for at least 2 months after study participation * HIV negative * No mental incapacity that would preclude giving informed consent * No moderate-to-severe high-frequency hearing loss * No persistent severe (grade 2) drug-induced peripheral neuropathy * No known allergy to cisplatin or any other platinum-containing compound * No serious or uncontrolled infection * No other medical condition or reason that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy Chemotherapy * Prior cisplatin allowed * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * Recovered from all prior therapy * No concurrent vitamins, antioxidants, herbal preparations, or supplements * Concurrent single tablet multivitamin allowed * No other concurrent investigational medications
References
Publications (1)
- RESULTDickson MA, Carvajal RD, Merrill AH Jr, Gonen M, Cane LM, Schwartz GK. A phase I clinical trial of safingol in combination with cisplatin in advanced solid tumors. Clin Cancer Res. 2011 Apr 15;17(8):2484-92. doi: 10.1158/1078-0432.CCR-10-2323. Epub 2011 Jan 21. PMID 21257722