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Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

NCT00580320•Virginia Commonwealth University

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Massey Cancer Center/Virginia Commonwealth University

Richmond, Virginia, United States

Key Dates

Start Date

September 1, 2004

Primary Completion Date

October 1, 2009

Completion Date

November 1, 2013

Last Updated

August 18, 2016

Enrollment

ACTUAL participants

Conditions

MelanomaSoft Tissue SarcomaParathyroid CarcinomaSmall Cell Carcinoma of the LungCarcinoid Tumors

Interventions

Dacarbazine and bortezomib

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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