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

This study has been completed.
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: December 18, 2007
Last updated: July 7, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Soft Tissue Sarcoma
Parathyroid Carcinoma
Small Cell Carcinoma of the Lung
Carcinoid Tumors
Drug: Dacarbazine and bortezomib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Resource links provided by NLM:

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Safety as measured by serious adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: September 2004
Study Completion Date: November 2013
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
dacarbazine + bortezomib
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)

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).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00580320

United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Virginia
Massey Cancer Center/Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Principal Investigator: Andrew Poklepovic, MD Massey Cancer Center
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University Identifier: NCT00580320     History of Changes
Other Study ID Numbers: MCC-03740
Study First Received: December 18, 2007
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
soft tissue sarcoma
APUD tumor

Additional relevant MeSH terms:
Carcinoid Tumor
Carcinoma, Small Cell
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015