image

PAZIT Study for Children and Young Adults With Relapsed or Refractory Sarcoma

RETURN TO LIST OF TRIALS
 


Purpose: This trials is for young patients—children and young adults—who have not responded to prior therapy for sarcoma or have relapsed. The trial is for a combination of one targeted therapy (pazopanib, a Tyrosine Kinase inhibitor) and two chemotherapies (irinotecan—intravenous/oral and temozolomide—oral). This is the first such study and if patients do well, there will be a follow-up phase II study.
Authoritative site for this trial:  At ClinicalTrials.gov
What is the treatment? Oral targeted therapy (pazopanib, a Tyrosine Kinase inhibitor) and two chemotherapies (irinotecan and temozolomide)
Is there a chance you'll get a placebo? No, this is not a placebo controlled trial (see glossary).
How old do you have to be? 6 years to 30 years old.
What phase study is this? Phase I (see glossary)
What includes you in trial?
  • BSA of at least 0.7 m^2 (see this site to calculate http://www.medcalc.com/body.html)
  • Patients must have either measurable or evaluable disease
  • A pathologist-verified diagnosis of the histopathology of the tumor either from the original diagnosis or on recurrence (see Glossary)
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy.
  • Prior treatment with pazopanib, irinotecan, temozolomide during which the disease did not progress.
  • Recovered from prior treatments (timing will depend on which was the prior treatment).
  • Liver, kidneys and blood tests close to normal.
    		•
    What excludes you from the trial?
  • Other current anti-cancer therapies.
  • Prior treatment with pazopanib, irinotecan, or temozolomide when the disease did progress.
  • Pregnancy or breast-feeding
  • Currently talking anti-inflammation drugs (like aspirin or ibuprofen)
  • Currently talking anti-coagulation drugs.
  • Currently talking anti-epilepsy medications that are “enzyme inducing.”
  • Active bleeding or recent spitting up/vomiting blood.
  • Recent major surgery.
    		•
    In USA? Yes
    Sites where the trial is offered:
    • UCSF Benioff Children's Hospital, Oakland Recruiting Oakland, California, , 94609 Contact: Jennifer Michlitsch, MD    510-428-3372    jmichlitsch@mail.cho.org            
    • UCSF Helen Diller Family Comprehensive Cancer Center Recruiting San Francisco, California, , 94158 Contact: Kieuhoa Vo, MD, MAS    415-476-3831    kieuhoa.vo@ucsf.edu  
    • Dana-Farber Cancer Institute Boston, Massachusetts, 02215  Steven DuBois, MD    617-632-5640    steve_dubois@dfci.harvard.edu       
    Contact information:
    • Danielle Handler 415-476-7910 Danielle.Handler@ucsf.edu
    • Eloise Graham 415-502-5793 Eloise.Graham@ucsf.edu