Stage IV Melanoma Clinical Trial
Official title:
Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma
Verified date | June 2014 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with stage IV melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have histologically confirmed melanoma of cutaneous or unknown origin (ocular primary and mucosal primary excluded); patients must have Stage IV disease - All patients must undergo a computed tomography (CT) or magnetic resonance imaging (MRI) of the brain within 42 days prior to registration that is negative for brain metastases; patients with a history of brain metastases are ineligible - Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT, or MRI scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria In Solid Tumors [RECIST] 1.1); the CT from a combined positron emission tomography (PET)/CT must not be used to document measurable disease unless it is of diagnostic quality - Sites must offer all patients participation in translational medicine studies and banking of paraffin embedded tissue and whole blood - Patients must not have received any prior systemic therapy for Stage IV disease except for noncytotoxic biologic agents (e.g., vaccines, cytokines, cell therapies that do not require cytotoxic agents); patients may have received prior treatment with up to two prior biological therapies - no cytotoxics or kinase inhibitors - for advanced disease - Patients may have had prior adjuvant immunotherapy with biological response modifiers (examples include but are not limited to interferon, vaccines, GM-CSF, and CTLA-4 blocking antibodies); prior adjuvant immunotherapy must have been completed at least 28 days prior to registration - Adjuvant therapy containing cytotoxic agents is allowed if completed >= 180 days prior to registration - Patients may have received prior radiation therapy; any side effects the patients had due to prior radiation therapy must have resolved to =< Grade 1 prior to registration; prior radiation therapy must have completed at least 28 days prior to registration - Patients must have Zubrod performance status of 0-1 - Leukocytes >= 3,000/mcL - Absolute neutrophil count (ANC) >= 1,500/mcL - Platelets >= 100,000/mcL - Hemoglobin >= 9 g/dL - Total bilirubin =< institutional upper limit of normal (IULN) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x IULN - Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min - Patients must have the following serum electrolytes within the institutional ranges of normal: potassium, sodium, magnesium, phosphorous, chloride and calcium (corrected for serum albumin); these tests must be performed within 28 days prior to registration; patient must not require parenteral replacement therapy - Patients must not have a history of allergic reaction attributed to compounds of similar chemical or biologic composition to RO4929097 - Patients must be able to swallow tablets - Patients must not have malabsorption syndrome or other condition that would interfere with intestinal absorption of the agent - Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin), are ineligible - Patients must not be taking strong inducers or strong inhibitors of CYP3A4 at the time of registration - Patients must not be known to be serologically positive for Hepatitis A, B, or C, or have a history of liver disease, other forms of hepatitis, or cirrhosis - Patients must have an ECG within 28 days prior to registration. Patients must not have a QTcF > 450 msec (males) or QTcF > 470 msec (females) - Patients must not have symptomatic congestive heart failure or unstable angina pectoris - Patients with a history of torsades de pointes or any significant cardiac arrhythmia (except asymptomatic unifocal ventricular premature beats or supraventricular tachycardia easily controlled with oral medications) are excluded; any patient requiring or expected to require antiarrhythmics or other therapy known to prolong QTc is also excluded - No other prior malignancy is allowed except for the following: 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 five years - Women of childbearing potential must have a negative pregnancy test within 14 days prior to registration (the type of pregnancy test used is at the discretion of the registering institution); female patients of childbearing potential include the following: - Patients with regular menses - Patients, after menarche with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding - Women who have had tubal ligation - Women must not be nursing due to possible harm to a nursing infant from the treatment regimen - All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pali Momi Medical Center | Aiea | Hawaii |
United States | Saint Anthony's Health | Alton | Illinois |
United States | Cancer Care Center at Island Hospital | Anacortes | Washington |
United States | AnMed Health Hospital | Anderson | South Carolina |
United States | Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Mission Hospital-Memorial Campus | Asheville | North Carolina |
United States | University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | Saint Francis Hospital and Health Centers | Beech Grove | Indiana |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington |
United States | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan |
United States | Billings Clinic | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies PC | Billings | Montana |
United States | Montana Cancer Consortium CCOP | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | Central Care Cancer Center-Carrie J Babb Cancer Center | Bolivar | Missouri |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | CoxHealth Cancer Center | Branson | Missouri |
United States | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington |
United States | Highline Medical Center-Main Campus | Burien | Washington |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | University of Chicago | Chicago | Illinois |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Columbus CCOP | Columbus | Ohio |
United States | Doctors Hospital | Columbus | Ohio |
United States | Grant Medical Center | Columbus | Ohio |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Genesis Medical Center - East Campus | Davenport | Iowa |
United States | Dayton CCOP | Dayton | Ohio |
United States | Good Samaritan Hospital - Dayton | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Samaritan North Health Center | Dayton | Ohio |
United States | Oakwood Hospital | Dearborn | Michigan |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Denver Veterans Administration Medical Center | Denver | Colorado |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Fairbanks Memorial Hospital | Fairbanks | Alaska |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLeod Regional Medical Center | Florence | South Carolina |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Saint Edward Mercy Medical Center | Ft. Smith | Arkansas |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | Wayne Memorial Hospital | Goldsboro | North Carolina |
United States | Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado |
United States | Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan |
United States | Mercy Health Saint Mary's | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | Wayne Hospital | Greenville | Ohio |
United States | Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Hays Medical Center | Hays | Kansas |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Oncare Hawaii Inc-Kuakini | Honolulu | Hawaii |
United States | Oncare Hawaii Inc-POB II | Honolulu | Hawaii |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital | Honolulu | Hawaii |
United States | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii |
United States | University of Hawaii | Honolulu | Hawaii |
United States | Promise Regional Medical Center-Hutchinson | Hutchinson | Kansas |
United States | Allegiance Health | Jackson | Michigan |
United States | Castle Medical Center | Kailua | Hawaii |
United States | Glacier Oncology PLLC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | North Kansas City Hospital | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Joseph Health Center | Kansas City | Missouri |
United States | Saint Luke's Cancer Institute | Kansas City | Missouri |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Truman Medical Center | Kansas City | Missouri |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Columbia Basin Hematology and Oncology PLLC | Kennewick | Washington |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Wellmont Holston Valley Hospital and Medical Center | Kingsport | Tennessee |
United States | Evergreen Hospital Medical Center | Kirkland | Washington |
United States | Thompson Cancer Survival Center | Knoxville | Tennessee |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri |
United States | University of Kentucky | Lexington | Kentucky |
United States | Liberty Hospital | Liberty | Missouri |
United States | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | Memorial Hospital Of Martinsville | Martinsville | Virginia |
United States | Fremont - Rideout Cancer Center | Marysville | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Montana Cancer Specialists | Missoula | Montana |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
United States | Providence Hospital | Mobile | Alabama |
United States | Louisiana State University Sciences Center- Monroe | Monroe | Louisiana |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Skagit Valley Hospital | Mount Vernon | Washington |
United States | Mercy Health Mercy Campus | Muskegon | Michigan |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | University of California Medical Center At Irvine-Orange Campus | Orange | California |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Saint Luke's South Hospital | Overland Park | Kansas |
United States | Via Christi Hospital-Pittsburg | Pittsburg | Kansas |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Saint Joseph Mercy Port Huron | Port Huron | Michigan |
United States | Adventist Medical Center | Portland | Oregon |
United States | SWOG | Portland | Oregon |
United States | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington |
United States | Kansas City CCOP | Prairie Village | Kansas |
United States | Reid Hospital and Health Care Services | Richmond | Indiana |
United States | University of Rochester | Rochester | New York |
United States | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan |
United States | University of California at Davis Cancer Center | Sacramento | California |
United States | Saint Mary's of Michigan | Saginaw | Michigan |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Saint John's Mercy Medical Center | Saint Louis | Missouri |
United States | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri |
United States | Saint Louis-Cape Girardeau CCOP | Saint Louis | Missouri |
United States | Salina Regional Health Center | Salina | Kansas |
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
United States | Group Health Cooperative-Seattle | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Minor and James Medical PLLC | Seattle | Washington |
United States | Pacific Medical Center-First Hill | Seattle | Washington |
United States | Swedish Medical Center-First Hill | Seattle | Washington |
United States | The Polyclinic | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Virginia Mason CCOP | Seattle | Washington |
United States | United General Hospital | Sedro-Woolley | Washington |
United States | Shawnee Mission Medical Center | Shawnee Mission | Kansas |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Highland Clinic | Shreveport | Louisiana |
United States | Louisiana State University Health Sciences Center Shreveport | Shreveport | Louisiana |
United States | Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Upstate Carolina CCOP | Spartanburg | South Carolina |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | Evergreen Hematology and Oncology PS | Spokane | Washington |
United States | CoxHealth South Hospital | Springfield | Missouri |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield | Missouri |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Iredell Memorial Hospital | Statesville | North Carolina |
United States | Saint Francis Hospital and Medical Center - Topeka | Topeka | Kansas |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | Tahoe Forest Cancer Center | Truckee | California |
United States | University of Arizona Health Sciences Center | Tucson | Arizona |
United States | Maui Memorial Medical Center | Wailuku | Hawaii |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Wenatchee Valley Medical Center | Wenatchee | Washington |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Clinton Memorial Hospital | Wilmington | Ohio |
United States | Metro Health Hospital | Wyoming | Michigan |
United States | Greene Memorial Hospital | Xenia | Ohio |
United States | Genesis HealthCare System | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 months | No | |
Primary | Overall survival | Up to 1 year | No | |
Secondary | Response rate (confirmed and unconfirmed complete or partial response) | Up to 3 years | No | |
Secondary | Toxicity rates as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Up to 3 years | Yes |
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