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

• ClinicalTrials.gov Identifier: NCT00580320
• Recruitment Status: Completed
• First Posted: December 24, 2007
• Last Update Posted: August 18, 2016
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Melanoma; Soft Tissue Sarcoma; Parathyroid Carcinoma; Small Cell Carcinoma of the Lung; Carcinoid Tumors	Drug: Dacarbazine and bortezomib	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
• Study Start Date: September 2004
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: November 2013

Arms and Interventions

Arm

Intervention/treatment

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)

Outcome Measures

Primary Outcome Measures :

1. Safety as measured by serious adverse events [ Time Frame: 4 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 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

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Andrew Poklepovic, MD; Massey Cancer Center

More Information

Additional Information:

Publication 

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT00580320
• Other Study ID Numbers: MCC-03740
• First Posted: December 24, 2007
• Last Update Posted: August 18, 2016
• Last Verified: August 2016

Keywords provided by Virginia Commonwealth University:

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

Additional relevant MeSH terms:

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