Status:
COMPLETED
Safingol and Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00084812
Start Date
March 1 2004
End Date
February 1 2009
Last Update
March 22 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021