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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301067 |
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of calcitriol when given together with temozolomide, and to see how well they work in treating patients with metastatic stage IV melanoma.
Condition | Intervention | Phase |
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Intraocular Melanoma Melanoma (Skin) |
Drug: calcitriol Drug: temozolomide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma |
Estimated Enrollment: | 28 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of calcitriol followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
Stage IV disease
Must have had at least 1 prior systemic therapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu |
Study Chair: | Timothy M. Kuzel, MD | Robert H. Lurie Cancer Center |
Investigator: | John Eklund, MD | Robert H. Lurie Cancer Center |
Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Timothy M. Kuzel ) |
Study ID Numbers: | CDR0000456777, NU-05M1, NU-0310-093, SPRI-NU-05M1 |
Study First Received: | March 8, 2006 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00301067 |
Health Authority: | Unspecified |
stage IV melanoma recurrent melanoma intraocular melanoma recurrent intraocular melanoma |
Eye Neoplasms Eye Diseases Temozolomide Recurrence Melanoma Neuroendocrine Tumors Calcitriol Calcium, Dietary |
Neuroectodermal Tumors Uveal melanoma Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular melanoma Neuroepithelioma Nevus |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Calcium Channel Agonists Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |
Membrane Transport Modulators Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Vasoconstrictor Agents Nevi and Melanomas Antineoplastic Agents, Alkylating Micronutrients Alkylating Agents |