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ACTIVE NOT RECRUITING

NCT00937937

PHASE2

Dinaciclib in Treating Patients With Stage IV Melanoma

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Official title: A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2009-07-01

Completion Date

2026-03-19

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Acral Lentiginous Melanoma Cutaneous Nodular Melanoma Lentigo Maligna Melanoma Low-CSD Melanoma Mucosal Melanoma Recurrent Melanoma Stage IV Cutaneous Melanoma AJCC v6 and v7

Interventions

DRUG

Dinaciclib

Given IV

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

Locations (190)

Providence Hospital

Mobile, Alabama, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Highlands Oncology Group - Rogers

Rogers, Arkansas, 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

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

El Camino Hospital

Mountain View, California, United States

Wilma Chan Highland Hospital

Oakland, California, 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

Tom K Lee Inc

Oakland, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Boca Raton Comprehensive Cancer Center

Boca Raton, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

South Georgia Medical Center/Pearlman Cancer Center

Valdosta, Georgia, United States

OSF Saint Anthony's Health Center

Alton, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, United States

Reid Health

Richmond, Indiana, United States

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

HaysMed

Hays, Kansas, United States

Hutchinson Regional Medical Center

Hutchinson, Kansas, United States

Cancer Center of Kansas-Independence

Independence, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Southwest Medical Center

Liberal, Kansas, United States

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Olathe Cancer Center

Olathe, Kansas, 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

Mercy Hospital Pittsburg

Pittsburg, Kansas, United States

Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, United States

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Salina Regional Health Center

Salina, Kansas, United States

AdventHealth Shawnee Mission

Shawnee Mission, Kansas, 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

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Associates In Womens Health

Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Wichita NCI Community Oncology Research Program

Wichita, Kansas, United States

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Baton Rouge General Medical Center

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, 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 Rogel Cancer Center

Ann Arbor, Michigan, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 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

Allegiance Health

Jackson, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Lake Huron Medical Center

Port Huron, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Henry Ford Health Warren Hospital

Warren, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

University Health Truman Medical Center

Kansas City, Missouri, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Saint Joseph Health Center

Kansas City, Missouri, United States

North Kansas City Hospital

Kansas City, Missouri, United States

Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, United States

Research Medical Center

Kansas City, Missouri, United States

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, United States

Liberty Hospital

Liberty, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Mercy Infusion Center - Chippewa

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Saint Louis-Cape Girardeau CCOP

St Louis, Missouri, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

Saint Vincent Healthcare

Billings, Montana, United States

Montana Cancer Consortium NCORP

Billings, Montana, United States

Saint Vincent Frontier Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 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

Northern Montana Hospital

Havre, Montana, United States

Saint Peter's Community Hospital

Helena, Montana, United States

Glacier Oncology PLLC

Kalispell, Montana, United States

Kalispell Medical Oncology

Kalispell, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Montana Cancer Specialists

Missoula, Montana, United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Community Medical Center

Missoula, Montana, United States

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Nevada Cancer Institute-Summerlin Campus

Las Vegas, Nevada, United States

University of Rochester

Rochester, New York, United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, United States

Southeast Clinical Oncology Research Consortium NCORP

Winston-Salem, North Carolina, United States

Grandview Hospital

Dayton, Ohio, United States

Good Samaritan Hospital - Dayton

Dayton, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Miami Valley Hospital North

Dayton, Ohio, United States

Dayton NCI Community Oncology Research Program

Dayton, Ohio, United States

Blanchard Valley Hospital

Findlay, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Wayne Hospital

Greenville, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Upper Valley Medical Center

Troy, Ohio, United States

Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center

Wilmington, Ohio, United States

Greene Memorial Hospital

Xenia, Ohio, United States

Saint Charles Health System

Bend, Oregon, United States

Providence Milwaukie Hospital

Milwaukie, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Adventist Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Salem Hospital

Salem, Oregon, United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

McLeod Regional Medical Center

Florence, South Carolina, United States

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

Saint Francis Hospital

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Butternut

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

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Self Regional Healthcare

Greenwood, South Carolina, United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Wellmont Holston Valley Hospital and Medical Center

Kingsport, Tennessee, United States

Covenant Health Cancer Centers

Knoxville, Tennessee, United States

Medical City Dallas Hospital

Dallas, Texas, United States

Scott and White Memorial Hospital

Temple, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Danville Regional Medical Center

Danville, Virginia, United States

Sovah Health Martinsville

Martinsville, Virginia, United States

Ballad Health Cancer Care - Norton

Norton, Virginia, United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Skagit Valley Hospital

Mount Vernon, Washington, United States

Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, United States

Harborview Medical Center