Trial record 1 of 1 for:
NCT00802880
Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma
This study is currently recruiting participants.
Verified December 2012 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00802880
First received: December 4, 2008
Last updated: December 31, 2012
Last verified: December 2012
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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 primary endpoint is to determine 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: response to treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine 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: 30 days post last treatment ] [ Designated as safety issue: Yes ]
- To 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: end of treatment ] [ Designated as safety issue: No ]
- To determine the overall tumor metabolic response as assessed by FDG-PET/CT performed at baseline and then after every three cycles of dacarbazine [ Time Frame: response ] [ Designated as safety issue: No ]
- To 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: response to treatment ] [ Designated as safety issue: No ]
- To determine the overall disease control rate by RECIST criteria to dacarbazine given until disease progression [ Time Frame: response to treatment ] [ Designated as safety issue: No ]
- To determine the time-to-progression and overall survival in patients treated with dacarbazine [ Time Frame: disease progression and overall survival ] [ Designated as safety issue: No ]
- To 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: response to treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: dacarbazine |
Drug: dacarbazine
dacarbazine 850mg/m2 IV over hour once every 3 weeks
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
To be enrolled in this study, patients must meet all of the following prerequisites:
- 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 17 yrs
- 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
Exclusion Criteria:
Patients will be excluded from the clinical trial on the basis of any of the following:
- 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
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. | |
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: | December 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Osteosarcoma Sarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013