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

Tracking Information

• First Submitted Date: December 18, 2007
• First Posted Date: December 24, 2007
• Last Update Posted Date: August 18, 2016
• Study Start Date: September 2004
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 18, 2007): Safety as measured by serious adverse events [ Time Frame: 4 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

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

Experimental: A

dacarbazine + bortezomib

Intervention: Drug: Dacarbazine and bortezomib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 7, 2014): 17
• Original Estimated Enrollment (submitted: December 18, 2007): 40
• Actual Study Completion Date: November 2013
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00580320
• Other Study ID Numbers: MCC-03740
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Virginia Commonwealth University
• Study Sponsor: Virginia Commonwealth University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Virginia Commonwealth University
• Verification Date: August 2016