Status:
COMPLETED
Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma
Lead Sponsor:
Washington University School of Medicine
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the overall best tumor response rate to dacarbazine given until disease progression as assessed by RECIST criteria, CT and clinical exams in patients with met...
Detailed Description
The two reasons why dacarbazine was eliminated from treatment options for patients with metastatic sarcoma included inability to effectively address the drug's major toxicities (emesis and neutropenia...
Eligibility Criteria
Inclusion
- Histologically proven diagnosis of soft tissue or bone sarcoma
- Metastatic or locally recurrent and unresectable sarcoma which progressed after one or more prior chemotherapy regimens (excluding adjuvant chemotherapy).
- At least one measurable tumor lesion (by CT scan) At least one FDG avid (SUV ≥ 3) tumor lesion (by PET/CT) which must have been performed at this institution. At least one of these target lesions must be ≥ 1.5 cm in smallest dimension as measured on the baseline CT
- Age greater than 18 yrs old
- ECOG Performance Status of 0-2
- Baseline ANC ≥ 1000/uL, Hgb ≥ 8 Gr/dL, platelets ≥ 100,000/ dL.
- Baseline serum creatinine \</= 2.0 mg/dL
- Baseline serum total bilirubin \</= 2.0, AST or ALT \< 3x ULN
- No active infection
- Signed Informed Consent by patient or legally authorized representative
Exclusion
- Current pregnancy or breast feeding.
- A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
- Chemotherapy, radiation therapy, or investigational agents given with the last 21 days.
- Investigational agents given with the last 30 days
- Uncontrolled diabetes mellitus. (Subjects with a fasting blood glucose \> 200 at time of PET scanning may need to reschedule to another day after consulting with appropriate physicians.)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00802880
Start Date
March 1 2009
End Date
January 1 2015
Last Update
February 13 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110