Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00802880
First received: December 4, 2008
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Sarcoma
Drug: Dacarbazine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determination of Tumor Response Rate by RECIST and FDG-PET Criteria to Dacarbazine in Metastatic Soft Tissue and Bone Sarcoma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The overall best tumor anatomic response rate to dacarbazine given until disease progression as assessed by RECIST criteria using CT and clinical examination in patients with metastatic sarcoma. [ Time Frame: After every 3 cycles of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The overall risk of nausea/emesis (any grade) and neutropenia (grade 3 or 4) with up to six cycles of dacarbazine given with current antiemetic agents and with pegfilgrastim [ Time Frame: Completion of 6 cycles of treatment ] [ Designated as safety issue: Yes ]
    Approximately 18 weeks

  • Compare the SUV at up to three target tumor sites as assessed by FDG-PET/CT performed at baseline and then after every three cycles of treatment with dacarbazine [ Time Frame: Baseline and after every three cycles of treatment ] [ Designated as safety issue: No ]
  • The overall tumor metabolic response as assessed by FDG-PET/CT performed at baseline and then after every three cycles of dacarbazine [ Time Frame: Baseline and after every three cycles of treatment ] [ Designated as safety issue: No ]
  • Correlate the tumor metabolic response to dacarbazine as assessed by PET/CT with the tumor anatomic response rate by RECIST criteria performed after every three cycles of dacarbazine [ Time Frame: After every three cycles of treatment ] [ Designated as safety issue: No ]
  • The overall disease control rate by RECIST criteria to dacarbazine given until disease progression [ Time Frame: After every 3 cycles of treatment ] [ Designated as safety issue: No ]
  • The time-to-progression and overall survival in patients treated with dacarbazine [ Time Frame: After every 3 cycles of treatment and then monthly for survival ] [ Designated as safety issue: No ]
  • Correlate the overall best tumor metabolic response to dacarbazine as assessed by FDG-PET/CT and to correlate the overall best tumor anatomic response to dacarbazine by RECIST criteria to TTP and OS [ Time Frame: After every three cycles of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dacarbazine
Dacarbazine 850 mg/m2 IV Day 1 of each 21 day cycle.
Drug: Dacarbazine
Other Names:
  • DTIC
  • DTIC-Dome
  • DIC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </= 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 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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802880

Contacts
Contact: Brian A Van Tine, M.D., Ph.D. 314-362-5817 bvantine@dom.wustl.edu
Contact: Kristina Williams 314-362-6963 kjwillia1@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Sub-Investigator: Douglas Adkins, M.D.         
Sub-Investigator: Jaisy Mathai, ANP         
Sub-Investigator: Barry Siegel, M.D.         
Sub-Investigator: Farrokh Dehdashti, M.D.         
Sub-Investigator: Kathryn Trinkaus, Ph.D.         
Principal Investigator: Brian Van Tine, M.D., Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Brian Van Tine, M.D., Ph.D. Washington Univerisity School of Medicine
  More Information

Additional Information:
Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00802880     History of Changes
Other Study ID Numbers: 08-1299 / 201109179
Study First Received: December 4, 2008
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sarcoma
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on October 02, 2014