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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082875 |
RATIONALE: Cilengitide may stop the growth of melanoma by stopping blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well cilengitide works in treating patients with unresectable stage III or stage IV melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: cilengitide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control |
Official Title: | A Phase II Study Of EMD 121974 (Cilengitide, NSC 707544) In Patients With Metastatic Melanoma |
Estimated Enrollment: | 56 |
Study Start Date: | March 2004 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to prior systemic treatment (yes vs no), visceral metastases (yes vs no), serum lactic dehydrogenase level (normal vs abnormal), and tumor integrin α_vβ_3 overexpression (yes vs no). Patients are randomized into 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 26-56 patients (13-28 per treatment arm) will be accrued for this study within 14-20 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma
Measurable disease
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No other malignancy within the past 5 years except for the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
No more than 1 prior systemic biotherapy or biochemotherapy regimen for stage IV disease
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent anticoagulant therapy (e.g., warfarin, heparin, or hirudin derivatives)
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Kevin Kim, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000360886, MDA-2003-0988, NCI-6387 |
Study First Received: | May 14, 2004 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00082875 History of Changes |
Health Authority: | United States: Federal Government |
stage III melanoma stage IV melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |