Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
72 participants
INTERVENTIONAL
2009-07-01
2026-03-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Dinaciclib
Given IV
Interventions
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Dinaciclib
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Christopher D Lao
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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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 Comprehensive 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
Thompson Cancer Survival Center
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
Seattle, Washington, United States
Minor and James Medical PLLC
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Kaiser Permanente Washington
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Saint Michael Cancer Center
Silverdale, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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References
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Lao CD, Moon J, Ma VT, Fruehauf JP, Flaherty LE, Bury MJ, Martin WG, Gross H, Akerley W, Hopkins JO, Patel SP, Sondak VK, Ribas A. Southwest Oncology Group S0826: A phase 2 trial of SCH 727965 (NSC 727135, dinaciclib) in patients with stage IV melanoma. Cancer. 2025 Jan 1;131(1):e35587. doi: 10.1002/cncr.35587. Epub 2024 Sep 29.
Other Identifiers
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NCI-2011-01935
Identifier Type: REGISTRY
Identifier Source: secondary_id
SWOG-S0826
Identifier Type: -
Identifier Source: secondary_id
CDR0000647155
Identifier Type: -
Identifier Source: secondary_id
S0826
Identifier Type: OTHER
Identifier Source: secondary_id
S0826
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-01935
Identifier Type: -
Identifier Source: org_study_id
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