Stage IV Melanoma Clinical Trial
Official title:
A Phase II Study of AZD2171 in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
Verified date | July 2018 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial is studying how well AZD2171 works in treating patients with recurrent or stage IV melanoma. AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
Status | Completed |
Enrollment | 24 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically/cytologically confirmed recurrent/metastatic malignant melanoma (stage IV acral lentiginous, lentigo maligna, superficial spreading or ocular malignant melanoma) - Measurable disease- at least 1 lesion accurately measured in at least 1 dimension (longest diameter) as >=20mm with conventional techniques or >=10mm with spiral CT scan - Previously irradiated lesions not considered measurable unless they demonstrated progression prior to study entry - No prior chemotherapy (including regional therapy); prior adjuvant immunotherapy permitted if completed >3 months prior to study entry; patients may have received prior radiation therapy if completed >=4 weeks prior to study entry - Previous surgery permissible if performed >=4 weeks prior to study entry - Life expectancy >12 weeks - ECOG performance status=< 2 (Karnofsky>=60%) - Leukocytes>=3,000/mcL - Absolute neutrophil count>=1,500/mcL - Platelets>=100,000/mcL - Hemoglobin>=8g/dL - Total bilirubin<1.5x institutional ULN (IULN) - AST/ALT=<3 x IULN (5xULN if liver metastases) - Creatinine within IULN - Creatinine within IULN OR - Creatinine clearance>=60mL/min/m^2 if creatinine levels above IULN - Baseline blood pressure <140/90mmHg; may be taking antihypertensive medications - AZD2171 has shown to terminate fetal development in rat as expected for process dependent on VEGF signaling; women of childbearing potential must have negative pregnancy test prior to study entry; women of childbearing potential/men must agree to use adequate contraception (hormonal/barrier method of birth control; abstinence) prior to study entry and for duration of study - Ability to understand/willingness to sign written informed consent Exclusion Criteria: - Any previous chemotherapy or immunotherapy for recurrent/metastatic disease; patients who have had radiotherapy or major surgery within 4 weeks prior to entering study or those who have not recovered from AEs due to treatment received more than 4 weeks earlier - May not be concurrently receiving other investigational agents nor have participated in an investigational trial of bio-, chemo- or immunotherapy agents - Known brain metastases because of their poor prognosis and because patients often develop progressive neurologic dysfunction that would confound evaluation of neurologic and other AEs - History of allergic reactions attributed to compounds of similar chemical/biologic composition to AZD2171 - Mean QTc>470msec (Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome - >+1 proteinuria on 2 consecutive dipsticks taken no less than 1 week apart - Uncontrolled intercurrent illness including but not limited to hypertension, ongoing/active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant women excluded from study because AZD2171 is a VEGF inhibitor with known abortifacient effects; breastfeeding should be discontinued if mother is treated with AZD2171 - HIV-positive patients on combination antiretroviral therapy are ineligible because of potential for PK interactions with AZD2171; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated - Any significant abnormality noted in ECG within 14 days of treatment - A NYHA classification of III or IV (NOTE: Patients classified as class II controlled with treatment may continue with increase monitoring) - Conditions requiring concurrent use of drugs/biologics with proarrhythmic potential; these drugs are prohibited during studies with AZD2171 |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital Phase 2 Consortium | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Tumor Response (Partial or Complete Response) According to RECIST | Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [J Nat Cancer Inst 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions, assessed by CT or MRI; Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." | Up to 6 years | |
Primary | Prolonged Stable Disease According to RECIST | Up to 6 months | ||
Secondary | Median Survival Time | Up to 6 years | ||
Secondary | Survival Rate | At 1 year | ||
Secondary | Response Duration | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 years | ||
Secondary | Stable Disease Duration | From the start of the treatment until the criteria for progression are met, assessed up to 6 years | ||
Secondary | Highest Toxicity Grade Assessed by NCI CTCAE Version 3.0 | Up to 6 years after completion of treatment | ||
Secondary | Time to Disease Progression | Up to 6 years | ||
Secondary | Clinical Benefit Response | Up to 6 years | ||
Secondary | Changes in Levels of Soluble Angiogenic Factors | From baseline to up to 6 years | ||
Secondary | Change in Vessel Permeability and Blood Flow by DCE-MRI | From baseline to up to 28 days after starting daily oral dosing |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02107755 -
Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Withdrawn |
NCT01216787 -
RO4929097 in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma That Can Be Removed by Surgery
|
Phase 2 | |
Active, not recruiting |
NCT01026324 -
Dinaciclib in Treating Patients With Stage III-IV Melanoma
|
Phase 1/Phase 2 | |
Completed |
NCT01010984 -
LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma
|
N/A | |
Completed |
NCT00553306 -
Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma
|
Phase 1/Phase 2 | |
Completed |
NCT00121225 -
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
|
Phase 2 | |
Completed |
NCT00019448 -
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT03200847 -
Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03235245 -
Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib
|
Phase 2 | |
Terminated |
NCT01875653 -
Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
|
Phase 3 | |
Completed |
NCT01748747 -
Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery
|
Early Phase 1 | |
Terminated |
NCT01316692 -
Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT01120275 -
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
Terminated |
NCT01166126 -
Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV
|
Phase 2 | |
Terminated |
NCT01026051 -
Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma
|
Phase 2 | |
Terminated |
NCT01217411 -
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
|
Phase 1 | |
Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
Completed |
NCT00288041 -
Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00072163 -
Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
|
Phase 2 | |
Completed |
NCT00074308 -
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
|
Phase 1/Phase 2 |