Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Texas Southwestern Medical Center
With
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The single patient treatment instructions for use are intended for a single patient with advanced soft tissue sarcoma. The patient will be treated with YONDELIS® (trabectedin) i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days, provided that he/she fulfills all eligibility criteria.
The patient may continue to receive therapy until there is evidence of disease progression or unacceptable toxicity. Safety will be evaluated and serious adverse events will be reported. Disease assessments will occur according to institutional practice.
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Signed informed consent.
2. 18 years-of-age or older.
3. Unresectable, advanced or metastatic, histologically proven soft tissue sarcoma.
4. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or better.
5. Hematologic variables:
* Hemoglobin ≥9 g/dL
* ANC ≥1,500/μL
* Platelet count ≥100,000/μL
6. Serum creatinine ≤ upper limit of normal (ULN)
7. Hepatic function variables:
* Total bilirubin ≤ ULN
* Total alkaline phosphatase ≤ ULN, or if \> ULN, then alkaline phosphatase liver fraction or 5'-nucleotidase must be ≤ ULN.
* AST (serum aspartate transaminase \[SGOT\]) and ALT (serum alanine transaminase \[SGPT\]) must be ≤ 2.5xULN
* Albumin ≥2.5 g/dL
You may not be if
1. Pregnant or breast-feeding women, or patients (male or female) not employing adequate contraception. Acceptable means of birth control include IUD, oral contraceptive, subdermal implant, and a condom with a contraceptive sponge or suppository.
2. Less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent
3. Active viral hepatitis or chronic liver disease
4. Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias
