Dinaciclib in Treating Patients With Stage IV Melanoma

Phase 2

Active, not recruiting

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

Registration Number: NCT00937937

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 72

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	Dinaciclib	Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Overall Survival	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

Name	Time	Method
Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)	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.
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST	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.
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	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.

Trial Locations

Locations (190): Providence Hospital
🇺🇸
Mobile, Alabama, United States
Henry Ford Health Warren Hospital
🇺🇸
Warren, Michigan, United States
Mercy Hospital Fort Smith
🇺🇸
Fort Smith, Arkansas, United States
HaysMed
🇺🇸
Hays, Kansas, 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
Highland General 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
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
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
Saint Louis Cancer and Breast Institute-South City
🇺🇸
Saint Louis, Missouri, United States
Mercy Hospital Saint Louis
🇺🇸
Saint Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP
🇺🇸
Saint 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