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Sponsored by: |
Virginia Commonwealth University |
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Information provided by: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00580320 |
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.
Condition | Intervention | Phase |
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Melanoma Soft Tissue Sarcoma Parathyroid Carcinoma Small Cell Carcinoma of the Lung Carcinoid Tumors |
Drug: Dacarbazine and bortezomib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma |
Estimated Enrollment: | 40 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
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
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
Contact: John D. Roberts, MD | 804-628-1940 | john.d.roberts@vcu.edu |
Contact: Christine A. Birdsell, RN | 804-828-0422 | cbirdsell@vcu.edu |
United States, Virginia | |
Massey Cancer Center/Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States, 23298 | |
Principal Investigator: John D. Roberts, MD |
Principal Investigator: | John D. Roberts, MD | Massey Cancer Center |
Responsible Party: | Virginia Commonwealth University ( John D. Roberts, MD ) |
Study ID Numbers: | MCC-03740 |
Study First Received: | December 18, 2007 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00580320 History of Changes |
Health Authority: | United States: Institutional Review Board |
melanoma soft tissue sarcoma APUD tumor |
dacarbazine bortezomib velcade |
Thoracic Neoplasms Parathyroid Diseases Dacarbazine Carcinoma, Neuroendocrine Melanoma Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Alkylating Agents Endocrine Gland Neoplasms Bortezomib |
Endocrine System Diseases Protease Inhibitors Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Parathyroid Neoplasms Malignant Mesenchymal Tumor Lung Diseases Head and Neck Neoplasms Sarcoma Carcinoid Tumor Antineoplastic Agents, Alkylating Endocrinopathy Nevus |
Thoracic Neoplasms Parathyroid Diseases Dacarbazine Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Melanoma Neoplasms, Connective and Soft Tissue Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas |
Alkylating Agents Endocrine Gland Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Bortezomib Endocrine System Diseases Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Parathyroid Neoplasms Neoplasms |