Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma

NCT00802880 | Completed Phase 2 Results

• 1 other identifier: 08-1299 / 201109179
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 metastatic sarcomas.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• Best Anatomical Tumor Response

  * 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

  After completion of 3 cycles

Secondary Outcomes (12)

• Rate of Neutropenia (Grade 3/4)

  Completion of 6 cycles of treatment (18 weeks)

• Rate of Nausea/Emesis (Any Grade)

  Completion of 6 cycles of treatment (18 weeks)

• Comparison of the SUV at up to 3 Tumor Sites

  Baseline and after every three cycles of treatment (up to 1 year)

• Overall Tumor Metabolic Response

  After completion of 3 cycles

• Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate

  After completion of 3 cycles

Study Arms (1)

Dacarbazine

EXPERIMENTAL

Dacarbazine 850 mg/m\^2 IV Day 1 of each 21 day cycle.

Drug: Dacarbazine

Interventions

Dacarbazine DRUG

Also known as: DTIC, DTIC-Dome, DIC

Dacarbazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• Antman K, Crowley J, Balcerzak SP, Rivkin SE, Weiss GR, Elias A, Natale RB, Cooper RM, Barlogie B, Trump DL, et al. An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. J Clin Oncol. 1993 Jul;11(7):1276-85. doi: 10.1200/JCO.1993.11.7.1276.

  PMID: 8315425 BACKGROUND

• Gottlieb JA, Benjamin RS, Baker LH, O'Bryan RM, Sinkovics JG, Hoogstraten B, Quagliana JM, Rivkin SE, Bodey GP Sr, Rodriguez V, Blumenschein GR, Saiki JH, Coltman C Jr, Burgess MA, Sullivan P, Thigpen T, Bottomley R, Balcerzak S, Moon TE. Role of DTIC (NSC-45388) in the chemotherapy of sarcomas. Cancer Treat Rep. 1976 Feb;60(2):199-203.

  PMID: 769974 BACKGROUND

• Buesa JM, Mouridsen HT, van Oosterom AT, Verweij J, Wagener T, Steward W, Poveda A, Vestlev PM, Thomas D, Sylvester R. High-dose DTIC in advanced soft-tissue sarcomas in the adult. A phase II study of the E.O.R.T.C. Soft Tissue and Bone Sarcoma Group. Ann Oncol. 1991 Apr;2(4):307-9. doi: 10.1093/oxfordjournals.annonc.a057942.

  PMID: 1868027 BACKGROUND

• Borden EC, Amato DA, Rosenbaum C, Enterline HT, Shiraki MJ, Creech RH, Lerner HJ, Carbone PP. Randomized comparison of three adriamycin regimens for metastatic soft tissue sarcomas. J Clin Oncol. 1987 Jun;5(6):840-50. doi: 10.1200/JCO.1987.5.6.840.

  PMID: 3585441 BACKGROUND

• Choi H, Charnsangavej C, Faria SC, Macapinlac HA, Burgess MA, Patel SR, Chen LL, Podoloff DA, Benjamin RS. Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. J Clin Oncol. 2007 May 1;25(13):1753-9. doi: 10.1200/JCO.2006.07.3049.

  PMID: 17470865 BACKGROUND

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Sarcoma

Interventions

Dacarbazine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Brian Van Tine, M.D., Ph.D.
• Organization: Washington University School of Medicine

bvantine@dom.wustl.edu

314-362-5817

Study Officials

• Brian Van Tine, M.D., Ph.D.

  Washington Univerisity School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: March 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 13, 2017
• Results First Posted: February 13, 2017

Record last verified: 2016-12

Locations

US (1)