Safingol and Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Safingol

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