Melanoma Clinical Trial
Dinaciclib in Treating Patients With Stage IV Melanoma
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.
Full 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.
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
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There are 161 Locations for this study
Mobile Alabama, 36608, United States
Fort Smith Arkansas, 72903, United States
Little Rock Arkansas, 72205, United States
Rogers Arkansas, 72758, United States
Castro Valley California, 94546, United States
Castro Valley California, 94546, United States
Castro Valley California, 94546, United States
Emeryville California, 94608, United States
Fremont California, 94538, United States
Martinez California, 94553, United States
Mountain View California, 94040, United States
Oakland California, 94602, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Pleasanton California, 94588, United States
Pleasanton California, 94588, United States
San Pablo California, 94806, United States
Fort Collins Colorado, 80524, United States
Hartford Connecticut, 06105, United States
Boca Raton Florida, 33486, United States
Orlando Florida, 32806, United States
Savannah Georgia, 31404, United States
Savannah Georgia, 31405, United States
Valdosta Georgia, 31602, United States
Alton Illinois, 62002, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Downers Grove Illinois, 60515, United States
Maywood Illinois, 60153, United States
Mount Vernon Illinois, 62864, United States
Springfield Illinois, 62781, United States
Beech Grove Indiana, 46107, United States
Richmond Indiana, 47374, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Hays Kansas, 67601, United States
Hutchinson Kansas, 67502, United States
Independence Kansas, 67301, United States
Kansas City Kansas, 66160, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
Liberal Kansas, 67905, United States
Newton Kansas, 67114, United States
Olathe Kansas, 66061, United States
Overland Park Kansas, 66209, United States
Overland Park Kansas, 66213, United States
Parsons Kansas, 67357, United States
Pittsburg Kansas, 66762, United States
Prairie Village Kansas, 66208, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Salina Kansas, 67401, United States
Shawnee Mission Kansas, 66204, United States
Topeka Kansas, 66606, United States
Topeka Kansas, 66606, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Baton Rouge Louisiana, 70806, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Boston Massachusetts, 02118, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Battle Creek Michigan, 49017, United States
Big Rapids Michigan, 49307, United States
Dearborn Michigan, 48124, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48236, United States
Flint Michigan, 48503, United States
Flint Michigan, 48532, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Muskegon Michigan, 49444, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
Traverse City Michigan, 49684, United States
Warren Michigan, 48093, United States
Wyoming Michigan, 49519, United States
Cape Girardeau Missouri, 63703, United States
Kansas City Missouri, 64108, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64114, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64118, United States
Kansas City Missouri, 64132, United States
Lee's Summit Missouri, 64086, United States
Liberty Missouri, 64068, United States
Saint Joseph Missouri, 64506, United States
Saint Joseph Missouri, 64507, United States
Saint Louis Missouri, 63109, United States
Saint Louis Missouri, 63141, United States
Saint Louis Missouri, 63141, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59102, United States
Billings Montana, 59102, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Havre Montana, 59501, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59802, United States
Missoula Montana, 59802, United States
Missoula Montana, 59804, United States
Missoula Montana, 59804, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89135, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28204, United States
Goldsboro North Carolina, 27534, United States
Pinehurst North Carolina, 28374, United States
Winston-Salem North Carolina, 27104, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45459, United States
Findlay Ohio, 45840, United States
Franklin Ohio, 45005, United States
Greenville Ohio, 45331, United States
Kettering Ohio, 45429, United States
Troy Ohio, 45373, United States
Wilmington Ohio, 45177, United States
Xenia Ohio, 45385, United States
Bend Oregon, 97701, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97213, United States
Portland Oregon, 97216, United States
Portland Oregon, 97225, United States
Salem Oregon, 97301, United States
Boiling Springs South Carolina, 29316, United States
Easley South Carolina, 29640, United States
Florence South Carolina, 29506, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greenwood South Carolina, 29646, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Kingsport Tennessee, 37660, United States
Knoxville Tennessee, 37916, United States
Dallas Texas, 75230, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Danville Virginia, 24541, United States
Martinsville Virginia, 24115, United States
Norton Virginia, 24273, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Kennewick Washington, 99336, United States
Mount Vernon Washington, 98274, United States
Poulsbo Washington, 98370, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Spokane Washington, 99202, United States
Spokane Washington, 99218, United States
Vancouver Washington, 98664, United States
Wenatchee Washington, 98801, United States
Casper Wyoming, 82609, United States
Sheridan Wyoming, 82801, United States
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