An Open-Labeled, Non-Randomized Phase I Study of Safingol Administered With Cisplatin in Patients With Advanced Solid Tumors
cisplatin
+ safingol
Neoplasms
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of safingol when administered with cisplatin in patients with locally advanced or metastatic solid tumors. Secondary * Determine the toxic effects of this regimen in these patients. * Determine the clinical pharmacokinetics of this regimen in these patients. * Determine, preliminarily, the therapeutic activity of this regimen in these patients. * Determine a safe dose (i.e., near the MTD) for phase II evaluation of this regimen in these patients. * Determine, preliminarily, the role of ceramide and S1P, relative to response and apoptosis, in patients treated with this regimen. OUTLINE: This is an open-label, non-randomized, dose-escalation study of safingol. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.43 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location