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Active Clinical Trials
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What Are Clinical Trials?

ACTIVE CLINICAL TRIALS
  PHASE I / II RSR13 
  
A PHASE I/II STUDY TO EVALUATE THE SAFETY, TOLERANCE, AND EFFICACY OF RSR13 ADMINISTERED TO PATIENTS RECEIVING A COURSE OF CISPLATIN AND RADIATION THERAPY FOR LOCALLY ADVANCED CARCINOMA OF THE CERVIX 

Eligibility Criteria
  1.   ³18 yrs of age
  2.  Documented local stage IIIB/IVA cervical malignancy that 
       doesn't extend below 1/3 of lower vagina
  3.  Stage IIB eligible for Phase II only
  4.  No prior cervical treatment unless conservatively in situ 
       (cryotherapy, cone biopsy)
  5.  No para-aortic nodal disease
  6.  No concurrent active malignancy from 2nd site.  
       Patients with prior malignancy must be disease free 
       for  ³5 yrs.
  7.  28 days before RT day 1 must not have used any 
       investigational drug, biologic or device
  8.  Medically acceptable use of birth control 
  9.  Resting and exercise SpO2  ³90% 
10.  Adequate blood, liver and kidney function 
11.  KPS ³70

Treatment
Patients will receive once weekly cisplatin administration (40mg/m2 intravenously, 5 total doses).

Patients will receive concurrent external beam radiation 
therapy (EBRT).

RSR13 will be administered to all patients prior to each 
EBRT treatment, except on the days of Cisplatin 
administration.

Patients will receive a total of 2 insertions of ICRT
beginning within one week of completion of EBRT.

RSR13 will be administered each day of ICRT.

Please contact Jamie Holt at 626-6800 for further information.