Clinical trial NCT00233948: Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma
Official title: A Phase I/II Study of Nelfinavir in Liposarcoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Adult Liposarcoma
Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2005-10-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 and to see how well it works in treating patients with recurrent, metastatic, or unresectable liposarcoma.

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 describe the toxicities at each does studied.

III. To evaluate the pharmacokinetics of nelfinavir. IV. To assess the response rate and progression free survival in patients with liposarcoma treated with nelfinavir.

V. To evaluate the expression and activity of certain proteins in the tumors of patients entered on this study, which may be important to the cytotoxicity of nelfinavir (SREBP-1, p21, NFkB (NFkappaB), caspase 3).

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility criteria: 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

Primary outcomes:
measure: Dose Limiting Toxicity (DLT) (Phase I)
timeFrame: 4 weeks from start of treatment, up to 2 years
measure: Maximum Tolerated Dose (MTD) (Phase I)
timeFrame: 4 weeks from start of treatment, up to 2 years
measure: Overall Response Rate (Phase II)
timeFrame: After 3 cycles of treatment, up to 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Pasadena
country: United States
facility: South Pasadena Cancer Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Warren Chow
role: PRINCIPAL_INVESTIGATOR
References: