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

NCT00580320 | Completed Phase 1 DMC

• 1 other identifier: MCC-03740
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Melanoma; Soft Tissue Sarcoma; Parathyroid Carcinoma; Small Cell Carcinoma of the Lung; Carcinoid Tumors

Keywords

melanoma; soft tissue sarcoma; APUD tumor; dacarbazine; bortezomib; velcade

Outcome Measures

Primary Outcomes (1)

• Safety as measured by serious adverse events

  4 years

Study Arms (1)

A

EXPERIMENTAL

dacarbazine + bortezomib

Drug: Dacarbazine and bortezomib

Interventions

Dacarbazine and bortezomib DRUG

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

Also known as: bortezomib (velcade)

A

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Massey Cancer Center/Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Links

• Publication

MeSH Terms

Conditions

Melanoma; Sarcoma; Parathyroid Neoplasms; Small Cell Lung Carcinoma; Carcinoid Tumor

Interventions

Dacarbazine; Bortezomib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• Andrew Poklepovic, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 24, 2007
• Study Start: September 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2013
• Last Updated: August 18, 2016

Record last verified: 2016-08

Locations

US (2)