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Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
This study is currently recruiting participants.
Verified by Virginia Commonwealth University, March 2009
First Received: December 18, 2007   Last Updated: March 6, 2009   History of Changes
Sponsored by: Virginia Commonwealth University
Information provided by: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00580320
  Purpose

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
Melanoma
Soft Tissue Sarcoma
Parathyroid Carcinoma
Small Cell Carcinoma of the Lung
Carcinoid Tumors
Drug: Dacarbazine and bortezomib
Phase I

MedlinePlus related topics: Cancer Carcinoid Tumors Lung Cancer Melanoma Soft Tissue Sarcoma
Drug Information available for: Bortezomib Dacarbazine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

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 ]

Estimated Enrollment: 40
Study Start Date: September 2004
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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

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).

  Eligibility

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

Inclusion Criteria:

  • Histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (STS), or an APUD (amine precursor uptake and decaroxylation) 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580320

Contacts
Contact: John D. Roberts, MD 804-628-1940 john.d.roberts@vcu.edu
Contact: Christine A. Birdsell, RN 804-828-0422 cbirdsell@vcu.edu

Locations
United States, Virginia
Massey Cancer Center/Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: John D. Roberts, MD            
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: John D. Roberts, MD Massey Cancer Center
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University ( John D. Roberts, MD )
Study ID Numbers: MCC-03740
Study First Received: December 18, 2007
Last Updated: March 6, 2009
ClinicalTrials.gov Identifier: NCT00580320     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
melanoma
soft tissue sarcoma
APUD tumor
dacarbazine
bortezomib
velcade

Study placed in the following topic categories:
Thoracic Neoplasms
Parathyroid Diseases
Dacarbazine
Carcinoma, Neuroendocrine
Melanoma
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Alkylating Agents
Endocrine Gland Neoplasms
Bortezomib
Endocrine System Diseases
Protease Inhibitors
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Parathyroid Neoplasms
Malignant Mesenchymal Tumor
Lung Diseases
Head and Neck Neoplasms
Sarcoma
Carcinoid Tumor
Antineoplastic Agents, Alkylating
Endocrinopathy
Nevus

Additional relevant MeSH terms:
Thoracic Neoplasms
Parathyroid Diseases
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Melanoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Alkylating Agents
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Bortezomib
Endocrine System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Parathyroid Neoplasms
Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009