- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00084812
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Safingol and Cisplatin
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recommended phase II dose as assessed by NCI toxicity scale during 3-4 weeks of treatment
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response as assessed by RECIST criteria during 3-6 weeks of treatment
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Gary K. Schwartz, MD, Memorial Sloan Kettering Cancer Center
- Principal Investigator: Archie N. Tse, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-002
- MSKCC-04002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unspecified Adult Solid Tumor, Protocol Specific
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingCollection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid TumorsUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Kantonsspital GraubuendenUnknownUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificSwitzerland
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Vanderbilt UniversityNational Cancer Institute (NCI)TerminatedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
University of ChicagoNational Cancer Institute (NCI)CompletedSirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By SurgeryUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)WithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyWithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Hematopoietic/Lymphoid CancerUnited States
-
University of Texas Southwestern Medical CenterRecruitingUnspecified Adult Solid Tumor, Protocol SpecificUnited States
Clinical Trials on cisplatin
-
West China Second University HospitalRecruitingNeoadjuvant Chemotherapy | Epithelial Carcinoma, OvarianChina
-
Insmed IncorporatedCompletedOsteosarcoma MetastaticUnited States
-
Privo TechnologiesNational Cancer Institute (NCI)CompletedOral Squamous Cell CarcinomaUnited States
-
Samsung Medical CenterUnknownNasophayngeal Carcinoma Between Stage II and IVbKorea, Republic of
-
Cedars-Sinai Medical CenterRecruitingHPV Positive Oropharyngeal Squamous Cell CarcinomaUnited States
-
Korea Cancer Center HospitalCompletedCervical CancersKorea, Republic of
-
Taiho Oncology, Inc.Quintiles, Inc.Completed
-
Sun Yat-sen UniversityActive, not recruitingNasopharyngeal CarcinomaChina
-
Lawson Health Research InstituteRecruitingLocally Advanced Head and Neck Squamous Cell CarcinomaCanada
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial People... and other collaboratorsActive, not recruitingNasopharyngeal Carcinoma | Nasopharyngeal Neoplasms | Nasopharyngeal Diseases | Head and Neck NeoplasmChina