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RTOG 0121 Protocol Information

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A Phase I/II Study of Neoadjuvant Chemotherapy, Angiogenesis Inhibitor SU5416 (NSC #696819; A TK Inhibitor Anti-Angiogenesis Compound), and Radiation Therapy in the Management of High-Risk, High-Grade, Soft Tissue Sarcomas of the Extremities and Body Wall
Protocol Documents
Current Version Date: 9/12/2001
Principal Investigator: Burton L. Eisenberg, M.D.
Primary Objective:

To determine the maximum tolerated dose (MTD) of SU5416 with this chemotherapy/radiation therapy treatment scheme

Patient Population:

 

  • Histologically confirmed, locally confined, soft tissue sarcoma, Grade 2 or 3 on scale of 1-3 or Grades 3 or 4 on a scale of 1-4, >/= 8 cm in maximum diameter by MRI or CT; Stage IIC and III (AJCC, 1998).
  • Sarcoma located on upper (includes shoulder) or lower (includes hip) extremities or on body wall
  • Zubrod </= 1
  • WBC>/=4,000 or ANC >/=1800, platelets >/=150,000, bilirubin </=1.5, creatinine </=1.5, AST and ALT </= 1.5 x ULN, PT, PTT < 1.25 times normal (prior to coumadin), Fibrin Split products < 2 x normal/ Fibrinogen >200 mg/d
  • Normal heart function (EF ³ 50%); Patients with a history of a bypass surgery may only be enrolled if the surgery occurred at least one year prior to enrollment and after consultation with a cardiologist to determine stability of disease.
  • No evidence of metastases; no concurrent malignancies or prior malignancies within preceding five years
  • No prior chemotherapy, radiation, or biotherapy
  • No minor surgery (e.g. port placement) less than two weeks prior to study entry; no major surgery less than four weeks prior to study entry
  • No history of a bleeding or clotting diathesis
  • No severe peripheral vascular disease
  • No contraindications to limb -salvage surgery
  • No known hypersensitiveity to E-coli derived proteins
  • No concomitant uncontrolled medical or psychiatric disorders or any condition which compromises the patient’s ability to give informed consent or to complete this study as judged by the investigator
  • Patients must not be pregnant or breastfeeding, and both genders must practice suitable contraception throughout the study.
  • Treatment must begin within two weeks after registration.
  • Patient must sign a study-specific consent form prior to registration.
Target Accrual: 74
Current Accrual: 3
Status: Terminated
Date: 10/18/2002
Participating Sites:
Alta Bates Summit Medical Center-Herrick Campus Berkeley CA
Bay Area Tumor Institute Oakland CA
California Pacific Medical Center-Pacific Campus San Francisco CA
Cleveland Clinic Akron General Akron OH
Cottonwood Hospital Medical Center Murray UT
Cross Cancer Institute Edmonton, Alberta
Dixie Medical Center Regional Cancer Center East St. George UT
Finley Hospital Dubuque IA
Fox Chase Cancer Center Philadelphia PA
Gundersen Lutheran Medical Center La Crosse WI
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
LDS Hospital Salt Lake City UT
Lehigh Valley Hospital-Cedar Crest Allentown PA
Massachusetts General Hospital Cancer Center Boston MA
Mills-Peninsula Medical Center San Mateo CA
Moffitt Cancer Center Tampa FL
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn NY
Roswell Park Cancer Institute Buffalo NY
Southeast Cancer Control Consortium CCOP Winston Salem NC
Sutter Health Western Division Cancer Research Group Novato CA
Union Hospital Terre Haute IN
University of California Davis Comprehensive Cancer Center Sacramento CA
Upstate Carolina CCOP Spartanburg SC
Updated: 4/8/2011

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