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Trial record 1 of 1 for:    NCT00802880
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Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00802880
First received: December 4, 2008
Last updated: December 20, 2016
Last verified: December 2016
  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: 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:
  • Best Anatomical Tumor Response [ Time Frame: After completion of 3 cycles ]
    • Complete response (CR): disappearance of all target lesions, disappearance of all non-target lesions, normalization of tumor level marker
    • Partial response (PR): at least 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal
    • Stable disease (SD): neither sufficient shrinkage in target lesions to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits of normal
    • Progressive disease (PD): at least 20% increase in the sum of the LD of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions


Secondary Outcome Measures:
  • Rate of Neutropenia (Grade 3/4) [ Time Frame: Completion of 6 cycles of treatment (18 weeks) ]
    • Grade 3 neutropenia = absolute neutrophil count of <1000 - 500/mm^3
    • Grade 4 neutropenia = absolute neutrophil count of <500/mm^3

  • Rate of Nausea/Emesis (Any Grade) [ Time Frame: Completion of 6 cycles of treatment (18 weeks) ]
    Approximately 18 weeks

  • Comparison of the SUV at up to 3 Tumor Sites [ Time Frame: Baseline and after every three cycles of treatment (up to 1 year) ]
  • Overall Tumor Metabolic Response [ Time Frame: After completion of 3 cycles ]
    • Complete metabolic response (CMR)-complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions.
    • Partial metabolic response (PMR)

      • Target lesions: 20% or greater decrease in maximum SUV from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.
      • Non-target lesions: decrease in total number of non-target lesions, without complete resolution of metabolically active disease, or unequivocal decrease in degree of FDG activity within >50% of the lesions. No unequivocal new lesions.
    • Stable metabolic disease (SMD): does not qualify for CMR, PMR, or PMD.
    • Progressive metabolic disease (PMD):

      • Unequivocal development of one more new metabolically active lesions
      • Target lesion: 20% or greater increase in maximum SUV from baseline.
      • Non-target lesions: unequivocal increase in FDG activity

  • Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate [ Time Frame: After completion of 3 cycles ]
  • Overall Disease Control Rate [ Time Frame: 12 months ]
  • Time to Progression (TTP) [ Time Frame: Until completion of follow-up (estimated to be 1 year) ]
    -Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  • Overall Survival [ Time Frame: Until completion of follow-up or patient death (estimated to be 1 year) ]
  • Correlate the Time to Progression With Best Anatomic Response [ Time Frame: Completion of follow-up (estimated to be 1 year) ]
    -Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  • Correlate Time to Progression With Best Metabolic Response [ Time Frame: Completion of follow-up (estimated to be 1 year) ]
    -Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  • Correlate Overall Survival With Best Anatomic Response [ Time Frame: Completion of follow-up (estimated to be 1 year) ]
  • Correlate Overall Survival With Best Metabolic Response [ Time Frame: Completion of follow-up (estimated to be 1 year) ]

Enrollment: 80
Study Start Date: March 2009
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dacarbazine
Dacarbazine 850 mg/m^2 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
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
Results First Received: June 16, 2016
Last Updated: December 20, 2016

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 May 22, 2017