Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
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ClinicalTrials.gov Identifier: NCT00580320 |
Recruitment Status :
Completed
First Posted : December 24, 2007
Last Update Posted : August 18, 2016
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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 |
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 (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 |

Arm | Intervention/treatment |
---|---|
Experimental: A
dacarbazine + bortezomib
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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) |
- Safety as measured by serious adverse events [ Time Frame: 4 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580320
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 |
Principal Investigator: | Andrew Poklepovic, MD | Massey Cancer Center |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00580320 |
Other Study ID Numbers: |
MCC-03740 |
First Posted: | December 24, 2007 Key Record Dates |
Last Update Posted: | August 18, 2016 |
Last Verified: | August 2016 |
melanoma soft tissue sarcoma APUD tumor |
dacarbazine bortezomib velcade |
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 |