Dinaciclib in Treating Patients With Stage IV Melanoma

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

Sponsors

Lead Sponsor: National Cancer Institute (NCI)

Source 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.

Overall Status Active, not recruiting
Start Date 2009-07-01
Primary Completion Date 2013-10-22
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Overall Survival Weekly, up to 3 years
Secondary Outcome
Measure Time Frame
Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) Disease assessment was performed every 6 weeks, up to 3 years.
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
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.
Enrollment 72
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dinaciclib

Description: Given IV

Arm Group Label: Arm I

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Christopher D Lao Principal Investigator Southwest Oncology Group
Location
Facility:
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, 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, 94553-3156, 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 University of Kansas Health System | 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
Saint Joseph Mercy Hospital | 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
Mercy Health Saint Mary's | Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan, 49503, United States
Allegiance Health | Jackson, Michigan, 49201, United States
Sparrow Hospital | Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital | Livonia, Michigan, 48154, United States
Mercy Health Mercy Campus | Muskegon, Michigan, 49444, United States
Saint Joseph Mercy Oakland | 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
Metro Health Hospital | Wyoming, Michigan, 49519, United States
Saint Francis Medical Center | Cape Girardeau, Missouri, 63703, United States
Truman Medical Centers | 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 Deaconess Hospital | Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana, 59701, United States
Benefis Healthcare- 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 Hospital | 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, 45005-1066, 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 | 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, 24115, 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 Research Center | Seattle, Washington, 98109, United States
Kaiser Permanente Washington | Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill | Seattle, Washington, 98122-4307, 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
Location Countries

United States

Verification Date

2020-11-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Arm I

Type: Experimental

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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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