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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acral Lentiginous Malignant Melanoma, Lentigo Maligna Malignant Melanoma, Mucosal Melanoma, Nodular Malignant Melanoma, Recurrent Melanoma, Stage IV Melanoma, Superficial Spreading Malignant Melanoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Christopher Lao

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-01935

NCT ID:

NCT00937937

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Acral Lentiginous Malignant Melanoma
  • Lentigo Maligna Malignant Melanoma
  • Mucosal Melanoma
  • Nodular Malignant Melanoma
  • Recurrent Melanoma
  • Stage IV Melanoma
  • Superficial Spreading Malignant Melanoma
  • Lentigo
  • Melanoma
  • Hutchinson's Melanotic Freckle

Name

Location

University of Washington Medical Center Seattle, Washington  98195-6043
Hurley Medical Center Flint, Michigan  48503
Medical City Dallas Hospital Dallas, Texas  75230
Loyola University Medical Center Maywood, Illinois  60153
South Georgia Medical Center Valdosta, Georgia  31603
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Boston Medical Center Boston, Massachusetts  02118
Via Christi Regional Medical Center Wichita, Kansas  67214
Scott and White Memorial Hospital Temple, Texas  76508
Group Health Cooperative Seattle, Washington  98112
Great Falls Clinic Great Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Harborview Medical Center Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Welch Cancer Center Sheridan, Wyoming  82801
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Poudre Valley Hospital Fort Collins, Colorado  80524
Salina Regional Health Center Salina, Kansas  67401
Mecosta County Medical Center Big Rapids, Michigan  49307
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Grandview Hospital Dayton, Ohio  45405
Danville Regional Medical Center Danville, Virginia  24541
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Highland General Hospital Oakland, California  94602
Miami Valley Hospital Dayton, Ohio  45409
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Menorah Medical Center Overland Park, Kansas  66209
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
North Kansas City Hospital Kansas City, Missouri  64116
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Northern Montana Hospital Havre, Montana  59501
Wayne Hospital Greenville, Ohio  45331
Clinton Memorial Hospital Wilmington, Ohio  45177
Adventist Medical Center Portland, Oregon  97216
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Baton Rouge General Medical Center Baton Rouge, Louisiana  70821-2511
Greene Memorial Hospital Xenia, Ohio  45385
Cancer Centers of the Carolinas - Grove Commons Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Seneca Seneca, South Carolina  29672
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Memorial Medical Center Springfield, Illinois  62781
McLeod Regional Medical Center Florence, South Carolina  29501
Metro Health Hospital Grand Rapids, Michigan  49506
Guardian Oncology and Center for Wellness Missoula, Montana  59804
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
Larry G Strieff MD Medical Corporation Oakland, California  94609
El Camino Hospital Mountain View, California  94040
Wayne State University Detroit, Michigan  48202
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah  84112
Cancer Centers of the Carolinas - Easley Easley, South Carolina  29640
Decatur Memorial Hospital Decatur, Illinois  62526
Louisiana State University Health Science Center New Orleans, Louisiana  70112
Montana Cancer Specialists Missoula, Montana  59807-7877
Boca Raton Comprehensive Cancer Center Boca Raton, Florida  33486
Memorial Health University Medical Center Savannah, Georgia  31404
Hays Medical Center Hays, Kansas  67601
Saint Edward Mercy Medical Center Ft. Smith, Arkansas  72903
Valley Medical Oncology Consultants-Castro Valley Castro Valley, California  94546
Eden Hospital Medical Center Castro Valley, California  94546
Valley Medical Oncology Consultants-Fremont Fremont, California  94538
Bay Area Breast Surgeons Inc Oakland, California  94609
Bay Area Tumor Institution CCOP Oakland, California  94609
Tom K Lee Inc Oakland, California  94609
Valley Medical Oncology Consultants Pleasanton, California  94588
Valley Care Health System - Pleasanton Pleasanton, California  94588
Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo, California  94806
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Saint Anthony's Health Alton, Illinois  62002
Good Samaritan Regional Medical Center Mt. Vernon, Illinois  62864
Hematology Oncology Consultants Limited Naperville, Illinois  60540
Saint Francis Hospital and Health Centers Beech Grove, Indiana  46107
Reid Hospital and Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Stormont-Vail Regional Health Center Topeka, Kansas  66604
Saint Francis Hospital and Medical Center - Topeka Topeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Medical Center of Louisiana New Orleans, Louisiana  70112
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Saint Mary's Health Care Grand Rapids, Michigan  49503
Spectrum Health at Butterworth Campus Grand Rapids, Michigan  49503
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Mercy Health Partners-Mercy Campus Muskegon, Michigan  49443
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Saint Luke's Hospital of Kansas City Kansas City, Missouri  64111
Saint Joseph Health Center Kansas City, Missouri  64114
Liberty Radiation Oncology Clinic Kansas City, Missouri  64116
Truman Medical Center Kansas City, Missouri  64108
Saint Louis-Cape Girardeau CCOP Saint Louis, Missouri  63141
Saint John's Mercy Medical Center Saint Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Billings Clinic Billings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Berdeaux, Donald MD (UIA Investigator) Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Community Medical Hospital Missoula, Montana  59801
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Kettering Medical Center Kettering, Ohio  45429
Upper Valley Medical Center Troy, Ohio  45373
Greenville CCOP Greenville, South Carolina  29615
Greenville Memorial Hospital Greenville, South Carolina  29605
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Minor and James Medical PLLC Seattle, Washington  98104
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
University of California Medical Center At Irvine-Orange Campus Orange, California  92868
Olathe Cancer Center Olathe, Kansas  66061
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
University of Michigan University Hospital Ann Arbor, Michigan  48109
Cancer Centers of the Carolinas - Faris Greenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Radiation Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas-Greer Medical Oncology Greer, South Carolina  29650
Skagit Valley Hospital Mt. Vernon, Washington  98273
Evergreen Hematology and Oncology PS Spokane, Washington  99218
Saint Luke's South Hospital Overland Park, Kansas  66213
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Saint Joseph Oncology Inc Saint Joseph, Missouri  64507
Saint Charles Medical Center-Bend Bend, Oregon  97701
Memorial Hospital Of Martinsville Martinsville, Virginia  24115
Cancer Care Center of Decatur Decatur, Illinois  62526
Southwest Oncology Group San Antonio, Texas  78245
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Via Christi Hospital-Pittsburg Pittsburg, Kansas  66762
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Bronson Battle Creek Battle Creek, Michigan  49017
Promise Regional Medical Center-Hutchinson Hutchinson, Kansas  65702
Saint Louis Cancer and Breast Institute-South City Saint Louis, Missouri  63109
Nevada Cancer Institute-Summerlin Campus Las Vegas, Nevada  89135
Self Regional Healthcare Greenwood, South Carolina  29646
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370