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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 CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
Loyola University Medical CenterMaywood, Illinois  60153
South Georgia Medical CenterValdosta, Georgia  31603
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Boston Medical CenterBoston, Massachusetts  02118
Via Christi Regional Medical CenterWichita, Kansas  67214
Scott and White Memorial HospitalTemple, Texas  76508
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Poudre Valley HospitalFort Collins, Colorado  80524
Salina Regional Health CenterSalina, Kansas  67401
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Grandview HospitalDayton, Ohio  45405
Danville Regional Medical CenterDanville, Virginia  24541
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Highland General HospitalOakland, California  94602
Miami Valley HospitalDayton, Ohio  45409
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Wayne HospitalGreenville, Ohio  45331
Clinton Memorial HospitalWilmington, Ohio  45177
Adventist Medical CenterPortland, Oregon  97216
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Greene Memorial HospitalXenia, Ohio  45385
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Memorial Medical CenterSpringfield, Illinois  62781
McLeod Regional Medical CenterFlorence, South Carolina  29501
Metro Health HospitalGrand Rapids, Michigan  49506
Guardian Oncology and Center for WellnessMissoula, Montana  59804
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Larry G Strieff MD Medical CorporationOakland, California  94609
El Camino HospitalMountain View, California  94040
Wayne State UniversityDetroit, Michigan  48202
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Huntsman Cancer Institute/University of UtahSalt Lake City, Utah  84112
Cancer Centers of the Carolinas - EasleyEasley, South Carolina  29640
Decatur Memorial HospitalDecatur, Illinois  62526
Louisiana State University Health Science CenterNew Orleans, Louisiana  70112
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Boca Raton Comprehensive Cancer CenterBoca Raton, Florida  33486
Memorial Health University Medical CenterSavannah, Georgia  31404
Hays Medical CenterHays, Kansas  67601
Saint Edward Mercy Medical CenterFt. Smith, Arkansas  72903
Valley Medical Oncology Consultants-Castro ValleyCastro Valley, California  94546
Eden Hospital Medical CenterCastro Valley, California  94546
Valley Medical Oncology Consultants-FremontFremont, California  94538
Bay Area Breast Surgeons IncOakland, California  94609
Bay Area Tumor Institution CCOPOakland, California  94609
Tom K Lee IncOakland, California  94609
Valley Medical Oncology ConsultantsPleasanton, California  94588
Valley Care Health System - PleasantonPleasanton, California  94588
Doctors Medical Center- JC Robinson Regional Cancer CenterSan Pablo, California  94806
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Saint Anthony's HealthAlton, Illinois  62002
Good Samaritan Regional Medical CenterMt. Vernon, Illinois  62864
Hematology Oncology Consultants LimitedNaperville, Illinois  60540
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Stormont-Vail Regional Health CenterTopeka, Kansas  66604
Saint Francis Hospital and Medical Center - TopekaTopeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Medical Center of LouisianaNew Orleans, Louisiana  70112
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Truman Medical CenterKansas City, Missouri  64108
Saint Louis-Cape Girardeau CCOPSaint Louis, Missouri  63141
Saint John's Mercy Medical CenterSaint Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Upper Valley Medical CenterTroy, Ohio  45373
Greenville CCOPGreenville, South Carolina  29615
Greenville Memorial HospitalGreenville, South Carolina  29605
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Olathe Cancer CenterOlathe, Kansas  66061
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
University of Michigan University HospitalAnn Arbor, Michigan  48109
Cancer Centers of the Carolinas - FarisGreenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Radiation OncologyGreer, South Carolina  29650
Cancer Centers of the Carolinas-Greer Medical OncologyGreer, South Carolina  29650
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Saint Luke's South HospitalOverland Park, Kansas  66213
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Saint Joseph Oncology IncSaint Joseph, Missouri  64507
Saint Charles Medical Center-BendBend, Oregon  97701
Memorial Hospital Of MartinsvilleMartinsville, Virginia  24115
Cancer Care Center of DecaturDecatur, Illinois  62526
Southwest Oncology GroupSan Antonio, Texas  78245
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Via Christi Hospital-PittsburgPittsburg, Kansas  66762
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Bronson Battle CreekBattle Creek, Michigan  49017
Promise Regional Medical Center-HutchinsonHutchinson, Kansas  65702
Saint Louis Cancer and Breast Institute-South CitySaint Louis, Missouri  63109
Nevada Cancer Institute-Summerlin CampusLas Vegas, Nevada  89135
Self Regional HealthcareGreenwood, South Carolina  29646
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370