Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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 metastatic sarcomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Dacarbazine

Criteria

Inclusion Criteria:

• 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
• Baseline serum total bilirubin
• No active infection

• Signed Informed Consent by patient or legally authorized representative

Exclusion Criteria:

• 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.)