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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDacarbazine and bortezomib

The study team can explain what participation involves.

Who it may be forMelanoma · Soft Tissue Sarcoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 18, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Virginia Commonwealth University

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Virginia Commonwealth University
Interventions being studied: Drug: Dacarbazine and bortezomib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Dartmouth Hitchcock Medical CenterLebanon, New Hampshire
Massey Cancer Center/Virginia Commonwealth UniversityRichmond, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 18, 2016. Always confirm current availability with the study team.

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