Melanoma Clinical Trial

Dinaciclib in Treating Patients With Stage IV Melanoma

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

72

Study ID:

NCT00937937

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 161 Locations for this study

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Providence Hospital
Mobile Alabama, 36608, United States
Mercy Hospital Fort Smith
Fort Smith Arkansas, 72903, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Highlands Oncology Group - Rogers
Rogers Arkansas, 72758, United States
East Bay Radiation Oncology Center
Castro Valley California, 94546, United States
Eden Hospital Medical Center
Castro Valley California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville California, 94608, United States
Valley Medical Oncology Consultants-Fremont
Fremont California, 94538, United States
Contra Costa Regional Medical Center
Martinez California, 94553, United States
El Camino Hospital
Mountain View California, 94040, United States
Highland General Hospital
Oakland California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
Bay Area Tumor Institute
Oakland California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland California, 94609, United States
Tom K Lee Inc
Oakland California, 94609, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Valley Care Health System - Pleasanton
Pleasanton California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton California, 94588, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo California, 94806, United States
Poudre Valley Hospital
Fort Collins Colorado, 80524, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford Connecticut, 06105, United States
Boca Raton Comprehensive Cancer Center
Boca Raton Florida, 33486, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Memorial Health University Medical Center
Savannah Georgia, 31404, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah Georgia, 31405, United States
South Georgia Medical Center/Pearlman Cancer Center
Valdosta Georgia, 31602, United States
Saint Anthony's Health
Alton Illinois, 62002, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Advocate Good Samaritan Hospital
Downers Grove Illinois, 60515, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Good Samaritan Regional Health Center
Mount Vernon Illinois, 62864, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove Indiana, 46107, United States
Reid Health
Richmond Indiana, 47374, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
HaysMed
Hays Kansas, 67601, United States
Hutchinson Regional Medical Center
Hutchinson Kansas, 67502, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
Cancer Center of Kansas-Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas-Liberal
Liberal Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Olathe Cancer Center
Olathe Kansas, 66061, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons Kansas, 67357, United States
Ascension Via Christi - Pittsburg
Pittsburg Kansas, 66762, United States
Kansas City NCI Community Oncology Research Program
Prairie Village Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Salina Regional Health Center
Salina Kansas, 67401, United States
Advent Health - Shawnee Mission Medical Center
Shawnee Mission Kansas, 66204, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka Kansas, 66606, United States
University of Kansas Health System Saint Francis Campus
Topeka Kansas, 66606, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates In Womens Health
Wichita Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
Baton Rouge General Medical Center
Baton Rouge Louisiana, 70806, United States
Mary Bird Perkins Cancer Center
Baton Rouge Louisiana, 70809, United States
Louisiana State University Health Science Center
New Orleans Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans Louisiana, 70112, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor Michigan, 48106, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Bronson Battle Creek
Battle Creek Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids Michigan, 49307, United States
Beaumont Hospital - Dearborn
Dearborn Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint Michigan, 48532, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids Michigan, 49503, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids Michigan, 49503, United States
Allegiance Health
Jackson Michigan, 49201, United States
University of Michigan Health - Sparrow Lansing
Lansing Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States
Trinity Health Muskegon Hospital
Muskegon Michigan, 49444, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac Michigan, 48341, United States
Lake Huron Medical Center
Port Huron Michigan, 48060, United States
Ascension Saint Mary's Hospital
Saginaw Michigan, 48601, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
University of Michigan Health - West
Wyoming Michigan, 49519, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
University Health Truman Medical Center
Kansas City Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Saint Joseph Health Center
Kansas City Missouri, 64114, United States
North Kansas City Hospital
Kansas City Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City Missouri, 64118, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Saint Joseph Oncology Inc
Saint Joseph Missouri, 64507, United States
Saint Louis Cancer and Breast Institute-South City
Saint Louis Missouri, 63109, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
Saint Louis Missouri, 63141, United States
Billings Clinic Cancer Center
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
Saint Vincent Healthcare
Billings Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings Montana, 59102, United States
Saint Vincent Frontier Cancer Center
Billings Montana, 59102, United States
Bozeman Health Deaconess Hospital
Bozeman Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls Montana, 59405, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Northern Montana Hospital
Havre Montana, 59501, United States
Saint Peter's Community Hospital
Helena Montana, 59601, United States
Glacier Oncology PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Montana Cancer Specialists
Missoula Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula Montana, 59802, United States
Community Medical Center
Missoula Montana, 59804, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
Nevada Cancer Institute-Summerlin Campus
Las Vegas Nevada, 89135, United States
University of Rochester
Rochester New York, 14642, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro North Carolina, 27534, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst North Carolina, 28374, United States
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem North Carolina, 27104, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton Ohio, 45406, United States
Miami Valley Hospital
Dayton Ohio, 45409, United States
Miami Valley Hospital North
Dayton Ohio, 45415, United States
Dayton NCI Community Oncology Research Program
Dayton Ohio, 45459, United States
Blanchard Valley Hospital
Findlay Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin Ohio, 45005, United States
Wayne Hospital
Greenville Ohio, 45331, United States
Kettering Medical Center
Kettering Ohio, 45429, United States
Upper Valley Medical Center
Troy Ohio, 45373, United States
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Wilmington Ohio, 45177, United States
Greene Memorial Hospital
Xenia Ohio, 45385, United States
Saint Charles Health System
Bend Oregon, 97701, United States
Providence Milwaukie Hospital
Milwaukie Oregon, 97222, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Adventist Medical Center
Portland Oregon, 97216, United States
Providence Saint Vincent Medical Center
Portland Oregon, 97225, United States
Salem Hospital
Salem Oregon, 97301, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs South Carolina, 29316, United States
Prisma Health Cancer Institute - Easley
Easley South Carolina, 29640, United States
McLeod Regional Medical Center
Florence South Carolina, 29506, United States
Greenville Health System Cancer Institute-Andrews
Greenville South Carolina, 29601, United States
Saint Francis Hospital
Greenville South Carolina, 29601, United States
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Self Regional Healthcare
Greenwood South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport Tennessee, 37660, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
Scott and White Memorial Hospital
Temple Texas, 76508, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
Sovah Health Martinsville
Martinsville Virginia, 24112, United States
Southwest VA Regional Cancer Center
Norton Virginia, 24273, United States
PeaceHealth Saint Joseph Medical Center
Bellingham Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton Washington, 98310, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Skagit Valley Hospital
Mount Vernon Washington, 98274, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo Washington, 98370, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical PLLC
Seattle Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States
Kaiser Permanente Washington
Seattle Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle Washington, 98122, United States
University of Washington Medical Center - Montlake
Seattle Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane Washington, 99218, United States
PeaceHealth Southwest Medical Center
Vancouver Washington, 98664, United States
Wenatchee Valley Hospital and Clinics
Wenatchee Washington, 98801, United States
Rocky Mountain Oncology
Casper Wyoming, 82609, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

72

Study ID:

NCT00937937

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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