Status:
TERMINATED
Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma
Lead Sponsor:
City of Hope Medical Center
Conditions:
Adult Liposarcoma
Recurrent Adult Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Antiviral drugs, such as nelfinavir mesylate, may help prevent cancer cells from spreading. PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir mesylate...
Detailed Description
OBJECTIVES: I. To assess the toxicity and tolerance of nelfinavir in patients with liposarcoma. II. To define the maximum tolerated dose (MTD) of nelfinavir when given daily as a single agent and to...
Eligibility Criteria
Inclusion
- Inclusion
- Patients must have histologically confirmed liposarcoma, which is recurrent, metastatic or unresectable
- There is no limit to prior chemotherapy regimens; in addition, patients may have prior radiation
- All patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (\>= 20 mm with conventional techniques or \>= 10mm with spiral CT scan); pleural effusions and ascites will not be considered measurable, but may be present in addition to the measurable lesion(s)
- ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2; patients should have an expected survival of at least 3 months
- Absolute neutrophil count \>= 1,000/ul
- Platelets \>= 75000/ul
- Total bilirubin =\< 2.0 g/dl
- AST(SGOT)/ALT(SGPT) =\< 2.0X institutional upper limit of normal
- Brain metastasis is not an exclusion; however, patients are only eligible if they have had successful control of the brain tumor(s) by surgery or radiation therapy
- All prior therapy must have been completed at least 3 weeks prior to the patient's entry on this trial
- No concurrent chemotherapy, radiotherapy, immunotherapy or other investigational agents
- Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; should a women become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and willingness to sign a written informed consent document
- Exclusion
- Patient has had prior treatment with or is currently taking a protease inhibitor
- Patients enrolled cannot be on the following medications: cisapride, triazolam, midazolam, ergot derivatives, amiodarone, quinidine, dihydropyridine calcium antagonists (amlodipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine), sildenafil, dilantin, rifampin or oral contraceptives
- Uncontrolled intercurrent illness
- Patients must have recovered from any expected toxicities of previous chemotherapy or radiation therapy
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00233948
Start Date
March 1 2006
Last Update
April 1 2015
Active Locations (2)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
South Pasadena Cancer Center
Pasadena, California, United States, 91030