CompletedPhase 1NCT00580320

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

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.

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

StatusCompleted
PhasePhase 1
U.S. locations2
SponsorVirginia Commonwealth University
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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

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

04
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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