Temsirolimus in Treating Patients With Metastatic Solid Tumor or Lymphoma That Cannot Be Removed … (NCT00275093) | Clinical Trial Compass
CompletedPhase 1
Temsirolimus in Treating Patients With Metastatic Solid Tumor or Lymphoma That Cannot Be Removed By Surgery Who Have Different Levels of Liver Function
United States130 participantsStarted 2005-12
Plain-language summary
This phase I trial is studying the side effects and best dose of temsirolimus in treating patients with metastatic solid tumor or lymphoma that cannot be removed by surgery who have different levels of liver function. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Temsirolimus may have different effects in patients who have changes in their liver function
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed solid tumor or lymphoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; all solid and lymphoma tumor types are eligible; patients with a liver mass (radiologically evident), elevated alpha-fetoprotein level (\>= 500 ng/mL), and positive serology for viral hepatitis or history of alcoholic cirrhosis consistent with a diagnosis of hepatocellular carcinoma will be eligible without the need for pathologic confirmation of the diagnosis
* Life expectancy of \>= 2 months
* ECOG performance status =\< 2 (KPS \>= 50)
* Absolute neutrophil count \>= 1,000/mcl, and
* Platelets \>= 100,000/mcl, and
* Serum creatinine =\< 1.5 x ULN OR calculated creatinine clearance \>= 60 mL/min/1.73 m\^2
* Patients with abnormal liver function will be eligible and will be grouped according to total bilirubin and AST (SGOT); no distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes; for patient stratification, liver function tests should be repeated within 72 hours of starting initial therapy
* Patients with biliary obstruction for which a shunt has been placed are eligible, provided the liver function tests have stabilized (two measurements at least tow days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function); the…
What they're measuring
1
RD, defined as the highest dose level at which less than 33% of at least six patients experience DLT