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Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00580320
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE December 18, 2007
First Posted Date  ICMJE December 24, 2007
Last Update Posted Date August 18, 2016
Study Start Date  ICMJE September 2004
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
Safety as measured by serious adverse events [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
Official Title  ICMJE Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
Brief Summary Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.
Detailed Description

The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly.

Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Soft Tissue Sarcoma
  • Parathyroid Carcinoma
  • Small Cell Carcinoma of the Lung
  • Carcinoid Tumors
Intervention  ICMJE Drug: Dacarbazine and bortezomib
Level 0: Dacarbazine 190 mg/m2 + Bortezomib 1.0 mg/m2; Level 1: Dacarbazine 250 mg/m2 + Bortezomib 1.0 mg/m2; Level 2: Dacarbazine 250 mg/m2 + Bortezomib 1.3 mg/m2; Level 3: Dacarbazine 250 mg/m2 + Bortezomib 1.6 mg/m2; Level 4: Dacarbazine 330 mg/m2 + Bortezomib 1.6 mg/m2; Level 5: Dacarbazine 440 mg/m2 + Bortezomib 1.6 mg/m2; Level 6: Dacarbazine 580 mg/m2 + Bortezomib 1.6 mg/m2
Other Name: bortezomib (velcade)
Study Arms  ICMJE Experimental: A
dacarbazine + bortezomib
Intervention: Drug: Dacarbazine and bortezomib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2014)
17
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2007)
40
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (STS), or an APUD (amine precursor uptake and decarboxylation) tumor. APUD tumors include parathyroid carcinoma, medullary carcinoma of the thyroid, small cell carcinoma of the lung, pheochromocytoma, islet cell tumors, carcinoid tumors, and malignant paraganglioma.
  • Measurable or evaluable disease not appropriate for resection and/or radiation with curative intent. Patients with small cell carcinoma must have extended stage disease or, if limited stage disease, must have received at least one prior systemic therapy.
  • Age 18 years or greater
  • ECOG Performance Status 0 or 1
  • Women must be post-menopausal, infertile as the result of a surgical procedure, or willing to use a medically accepted form of birth control (abstinence, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condon with spermicide) for the duration of study treatment. Men also must agree to use a medically accepted form of birth control for the duration of study treatment.

Exclusion Criteria:

  • Uncontrolled brain metastatic disease
  • Platelet count <100
  • Absolute neutrophil count <1.5
  • Blood transfusion or hematopoietic growth factors for cytopenia within one month of enrollment.
  • Calculated or measured (Cockcroft and Gault formula) creatinine clearance <30 mL/minute
  • AST > 3 times the upper limit of normal, unless elevation due to metastatic disease, in which case AST > 5 times the upper limit of normal
  • Bilirubin > 2 mg/mL
  • Grade 2 or greater peripheral neuropathy
  • Hypersensitivity to bortezomib, boron, mannitol, or dacarbazine
  • Pregnant or nursing
  • Other investigational drugs within 14 days of enrollment
  • Other medical or other condition(s) that in the opinion of the investigator/sub-investigator might compromise the objectives of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00580320
Other Study ID Numbers  ICMJE MCC-03740
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Poklepovic, MD Massey Cancer Center
PRS Account Virginia Commonwealth University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP