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Dinaciclib in Treating Patients With Stage IV Melanoma

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ClinicalTrials.gov Identifier: NCT00937937
Recruitment Status : Active, not recruiting
First Posted : July 13, 2009
Results First Posted : July 22, 2016
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Acral Lentiginous Melanoma Lentigo Maligna Melanoma Mucosal Melanoma Nodular Melanoma Recurrent Melanoma Stage IV Cutaneous Melanoma AJCC v6 and v7 Superficial Spreading Melanoma Drug: Dinaciclib Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma
Actual Study Start Date : July 1, 2009
Actual Primary Completion Date : October 22, 2013


Arm Intervention/treatment
Experimental: 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.
Drug: Dinaciclib
Given IV
Other Names:
  • CDK Inhibitor SCH 727965
  • MK-7965
  • SCH 727965




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Weekly, up to 3 years ]
    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.


Secondary Outcome Measures :
  1. Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Disease assessment was performed every 6 weeks, up to 3 years. ]
    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.

  2. Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST [ Time Frame: Disease assessments for response were performed every 6 weeks, up to 3 years ]
    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.

  3. Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs [ Time Frame: Toxicity assessment was evaluated after each cycle (21 days), up to 3 years. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937937


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Locations
United States, Alabama
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Arkansas
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States, 72903
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Highlands Oncology Group-Rogers
Rogers, Arkansas, United States, 72758
United States, California
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States, 94546
Bay Area Breast Surgeons Inc
Emeryville, California, United States, 94608
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States, 94538
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
El Camino Hospital
Mountain View, California, United States, 94040
Highland General Hospital
Oakland, California, United States, 94602
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Bay Area Tumor Institute
Oakland, California, United States, 94609
Hematology and Oncology Associates-Oakland
Oakland, California, United States, 94609
Tom K Lee Inc
Oakland, California, United States, 94609
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Valley Care Health System - Pleasanton
Pleasanton, California, United States, 94588
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States, 94806
United States, Colorado
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
United States, Florida
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, United States, 33486
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
United States, Georgia
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, United States, 31602
United States, Illinois
Saint Anthony's Health
Alton, Illinois, United States, 62002
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
AMG Oncology - Naperville
Naperville, Illinois, United States, 60540
Memorial Medical Center
Springfield, Illinois, United States, 62781
United States, Indiana
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, United States, 46107
Reid Health
Richmond, Indiana, United States, 47374
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Hays Medical Center
Hays, Kansas, United States, 67601
Hutchinson Regional Medical Center
Hutchinson, Kansas, United States, 67502
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67905
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Olathe Cancer Center
Olathe, Kansas, United States, 66061
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Salina Regional Health Center
Salina, Kansas, United States, 67401
Shawnee Mission Medical Center-KCCC
Shawnee Mission, Kansas, United States, 66204
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, United States, 66606
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States, 49307
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States, 48124
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Ascension Saint John Hospital
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Lake Huron Medical Center
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Munson Medical Center
Traverse City, Michigan, United States, 49684
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Missouri
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Center
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64507
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Montana Cancer Consortium NCORP
Billings, Montana, United States, 59102
Saint Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59804
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Nevada Cancer Institute-Summerlin Campus
Las Vegas, Nevada, United States, 89135
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States, 45420
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oregon
Saint Charles Health System
Bend, Oregon, United States, 97701
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Adventist Medical Center
Portland, Oregon, United States, 97216
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
SWOG
Portland, Oregon, United States, 97239
Salem Hospital
Salem, Oregon, United States, 97301
United States, South Carolina
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States, 29601
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States, 37660
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Sovah Health Martinsville
Martinsville, Virginia, United States, 24115
Southwest VA Regional Cancer Center
Norton, Virginia, United States, 24273
United States, Washington
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Harborview Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Kaiser Permanente Washington
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center
Seattle, Washington, United States, 98195
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States, 98801
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Christopher Lao Southwest Oncology Group

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00937937     History of Changes
Other Study ID Numbers: NCI-2011-01935
NCI-2011-01935 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S0826
CDR0000647155
S0826 ( Other Identifier: SWOG )
S0826 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2009    Key Record Dates
Results First Posted: July 22, 2016
Last Update Posted: September 13, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Lentigo
Hutchinson's Melanotic Freckle
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases