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PS-341 in Treating Patients With Metastatic Malignant Melanoma
This study has been completed.
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024011
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic malignant melanoma.


Condition Intervention Phase
Melanoma (Skin)
Drug: bortezomib
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of PS-341 in the Treatment of Metastatic Malignant Melanoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2001
Detailed Description:

OBJECTIVES: I. Determine the progression-free survival at 18 weeks and overall survival of patients with metastatic malignant melanoma treated with PS-341. II. Determine the objective response rate of patients treated with this drug. III. Correlate p27 levels in tumor tissue with objective response rate in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3-6 months for up to 2 years after registration.

PROJECTED ACCRUAL: A total of 22-50 patients will be accrued for this study within 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic malignant melanoma At least 1 measurable lesion At least 2.0 cm in longest dimension No truly non-measurable lesions including the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions No known brain metastases requiring active treatment

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris or cardiac arrhythmia Other: No known allergy to compound of similar chemical or biologic composition to PS-341 No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: More than 4 weeks since prior immunotherapy or biologic therapy and recovered No concurrent immunotherapy Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: More than 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational therapy No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial agents for treatment of melanoma

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024011

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, District of Columbia
Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Svetomir Markovic, MD, PhD Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000068883, MAYO-MC007A, NCI-3293
Study First Received: September 13, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00024011  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Bortezomib
Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Nevi and Melanomas
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009