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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00937937
Other study ID # NCI-2011-01935
Secondary ID NCI-2011-01935SW
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2009
Est. completion date March 8, 2025

Study information

Verified date March 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Description:

PRIMARY OBJECTIVES: I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib. SECONDARY OBJECTIVES: I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease. III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma. OUTLINE: This is a multicenter study. Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 72
Est. completion date March 8, 2025
Est. primary completion date October 22, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Biopsy-confirmed malignant melanoma - Stage IV disease - Cutaneous or mucosal origin - Melanoma of unknown primary allowed - No ocular melanoma - Measurable or non-measurable disease - No prior or concurrent brain metastases as confirmed by CT scan or MRI - Zubrod performance status 0-1 - ANC = 1,500/mm^3 - Platelet count = 100,000/mm^3 - Hemoglobin = 9 g/dL - Serum bilirubin = 1.5 times upper limit of normal (ULN) (including patients with hepatic metastases) - SGOT or SGPT = 2.5 times ULN (= 5 times ULN in the presence of hepatic metastases) - Serum creatinine = 1.5 times ULN - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years - No prior therapy with a cyclin-dependent kinase inhibitor - At least 14 days since prior radiotherapy - At least 28 days since prior systemic chemotherapy - At least 28 days since prior adjuvant systemic therapy - At least 28 days since prior surgery - No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to = grade 1 - Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy - Therapy for stage IV resected free-of-disease will be considered adjuvant therapy - Prior radiotherapy allowed provided any side effects have resolved to = grade 1 - Prior surgery (for both the primary and stage IV disease) allowed provided side effects have resolved to = grade 1 - No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy) - No concurrent CYP3A4 inhibitors or inducers - No concurrent grapefruit or grapefruit juice

Study Design


Intervention

Drug:
Dinaciclib
Given IV

Locations

Country Name City State
United States Saint Anthony's Health Alton Illinois
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Baton Rouge General Medical Center Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Saint Charles Health System Bend Oregon
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Boca Raton Comprehensive Cancer Center Boca Raton Florida
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Boston Medical Center Boston Massachusetts
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Rocky Mountain Oncology Casper Wyoming
United States East Bay Radiation Oncology Center Castro Valley California
United States Eden Hospital Medical Center Castro Valley California
United States Valley Medical Oncology Consultants-Castro Valley Castro Valley California
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Medical City Dallas Hospital Dallas Texas
United States Danville Regional Medical Center Danville Virginia
United States Dayton NCI Community Oncology Research Program Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Advocate Good Samaritan Hospital Downers Grove Illinois
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Bay Area Breast Surgeons Inc Emeryville California
United States Blanchard Valley Hospital Findlay Ohio
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Poudre Valley Hospital Fort Collins Colorado
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Valley Medical Oncology Consultants-Fremont Fremont California
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Greenville Health System Cancer Institute-Andrews Greenville South Carolina
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Self Regional Healthcare Greenwood South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Northern Montana Hospital Havre Montana
United States HaysMed Hays Kansas
United States Saint Peter's Community Hospital Helena Montana
United States Hutchinson Regional Medical Center Hutchinson Kansas
United States Cancer Center of Kansas-Independence Independence Kansas
United States Allegiance Health Jackson Michigan
United States Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Joseph Health Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States University Health Truman Medical Center Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Kettering Medical Center Kettering Ohio
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee
United States Thompson Cancer Survival Center Knoxville Tennessee
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Nevada Cancer Institute-Summerlin Campus Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Southwest Medical Center Liberal Kansas
United States Liberty Radiation Oncology Center Liberty Missouri
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Contra Costa Regional Medical Center Martinez California
United States Sovah Health Martinsville Martinsville Virginia
United States Loyola University Medical Center Maywood Illinois
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Community Medical Center Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Providence Hospital Mobile Alabama
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Skagit Valley Hospital Mount Vernon Washington
United States El Camino Hospital Mountain View California
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Louisiana State University Health Science Center New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Kansas - Newton Newton Kansas
United States Southwest VA Regional Cancer Center Norton Virginia
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States Hematology and Oncology Associates-Oakland Oakland California
United States Highland General Hospital Oakland California
United States Tom K Lee Inc Oakland California
United States Olathe Cancer Center Olathe Kansas
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Orlando Health Cancer Institute Orlando Florida
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States Valley Care Health System - Pleasanton Pleasanton California
United States Valley Medical Oncology Consultants Pleasanton California
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Adventist Medical Center Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Kansas City NCI Community Oncology Research Program Prairie Village Kansas
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Reid Health Richmond Indiana
United States University of Rochester Rochester New York
United States Highlands Oncology Group - Rogers Rogers Arkansas
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Saint Louis-Cape Girardeau CCOP Saint Louis Missouri
United States Salem Hospital Salem Oregon
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Memorial Health University Medical Center Savannah Georgia
United States Fred Hutchinson Cancer Center Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Kaiser Permanente Washington Seattle Washington
United States Minor and James Medical PLLC Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Advent Health - Shawnee Mission Medical Center Shawnee Mission Kansas
United States Welch Cancer Center Sheridan Wyoming
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Evergreen Hematology and Oncology PS Spokane Washington
United States Memorial Medical Center Springfield Illinois
United States Scott and White Memorial Hospital Temple Texas
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Upper Valley Medical Center Troy Ohio
United States South Georgia Medical Center/Pearlman Cancer Center Valdosta Georgia
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Wenatchee Valley Hospital and Clinics Wenatchee Washington
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center Wilmington Ohio
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina
United States University of Michigan Health - West Wyoming Michigan
United States Greene Memorial Hospital Xenia Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. Weekly, up to 3 years
Secondary Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause. Disease assessment was performed every 6 weeks, up to 3 years.
Secondary Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Disease assessments for response were performed every 6 weeks, up to 3 years
Secondary Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event. Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
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