Iris Melanoma Clinical Trial
Official title:
A Randomized Phase ll Study of Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma
Verified date | March 2024 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase II trial studies how well sunitinib malate or valproic acid works in preventing high-risk uveal (eye) melanoma from spreading to other parts of the body. Sunitinib malate may stop the transmission of growth signals into tumor cells and prevents these cells from growing. Valproic acid may change the expression of some genes in uveal melanoma and suppress tumor growth.
Status | Active, not recruiting |
Enrollment | 210 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >= 18 years old - Histologically-confirmed primary uveal melanoma - Definitive local treatment for primary tumor, including surgical resection (enucleation) or radiation therapy (radioactive plaque or external proton beam) - High risk for distal recurrence defined as any of the following conditions: A) Confirmed both monosomy 3 and 8q amplification; B) Class II tumor - Less than 6 months from the date that local treatment (surgical or radiation) of the primary tumor was finalized - Karnofsky performance status (PS) scores of 70 or greater - If female, no pregnancy - If of child-bearing potential (< one year post-menopausal), must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, condom, diaphragm with spermicidal, cervical cap, abstinence or sterile sex partner) from the time informed consent is signed (women only) or the time of initiation of sunitinib (sunitinib malate) (men only); both men and women must agree to continue using such precautions while receiving sunitinib or valproic acid and for 30 days after the final dose - Absolute neutrophil count (ANC) >= 1500/mm^3 - Platelets >= 100,000/mm^3 - Hemoglobin >= 8 g/dl - Serum creatinine < 1.5 times upper limit of normal range (ULN) or creatinine clearance >= 40 ml/min - Serum bilirubin < 1.5 times ULN - Serum albumin > 2.0 g/dl - Adequate cardiac function (ejection fraction [EF] > 50%) based on multi gated acquisition (MUGA) scan or 2 dimensional-echocardiogram (2D-Echo) - Life expectancy of at least 5 years Exclusion Criteria: - Other malignancy within 5 years, except curatively treated non-melanomatous skin cancer, curatively treated carcinoma in situ of the uterine cervix, or early stage (stage I or IIa) prostate cancer - Metastatic uveal melanoma - History of severe allergic reaction to sunitinib or valproic acid; inability to receive sunitinib or valproic acid - Previous treatment with sunitinib or valproic acid for uveal melanoma - Active treatment with valproic acid for non-oncological conditions, if this cannot be safely switched to an alternative agent - Active epilepsy or convulsive conditions that require continuous use of anticonvulsants - Patients with known urea cycle disorders (i.e.: ornithine transcarbamylase deficiency) - Severe cardiovascular disease within 6 months, including myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebro-vascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias, uncontrollable hypertension or QT prolongation syndrome - Active liver disease (i.e., cirrhosis, viral or autoimmune hepatitis, etc.) - Pregnancy or unwillingness to stop breast-feeding - Prior myelosuppressive chemotherapy or other investigational drug therapy within the last 6 months prior to initiation of sunitinib or valproic acid - Current evidence of hematemesis, melena or gross hematuria - History or presence of any significant bleeding disorders - Concurrent use of a strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor or inducer; these medications should be discontinued or switched to a different medication with a weaker CYP3A4 interaction prior to enrollment into the study; if patients need to continue the same medication(s), they are excluded from the study - Chronic usage of aspirin greater than 81 mg/day - Unable to render informed consent and to follow protocol requirements - Any other medical condition(s) that, at the discretion of the principal investigator (PI), would make the patient inappropriate for this study |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival (Cohort 1) | OS distribution will be summarized using the method of Kaplan-Meier and the 2-year OS rate with two-sided 90% confidence interval (CI) will be provided. OS will be compared to the historic OS using a one-sample log-rank test. | Time of definitive treatment of the primary tumor until death from any cause, assessed at 2 years | |
Primary | Relapse-free survival (RFS) (Cohort 2 and 3) | RFS distribution will be summarized using the method of Kaplan-Meier. 1.5-year, 2-year PFS rate will be computed with the corresponding two-sided 90% confidence intervals. OS and RFS will be compared to the null hypothesis OS or RFS using a one-sided one-sample Brookmeyer-Crowley test with alpha 0.05 | Time of definitive treatment of the primary tumor until confirmed metastatic relapse or death from any cause, assessed at 2 years | |
Secondary | Relapse-free survival (Cohort 1) | RFS distribution will be summarized using the method of Kaplan-Meier, and two-sided 90% confidence interval (CI) will be provided. | Time of definitive treatment of the primary tumor until confirmed metastatic relapse or death from any cause, assessed at 2 years | |
Secondary | Overall survival (Cohort 2) | OS distribution will be summarized using the method of Kaplan-Meier and the 2-year OS rate with two-sided 90% confidence interval (CI) will be provided. OS will be compared to the historic OS using a one-sample log-rank test. | Time of definitive treatment of the primary tumor until death from any cause, assessed at 2 years | |
Secondary | Tolerability, defined as the proportion of patients able to complete 6 months of treatment, including those who underwent dose reduction | Proportion of patients completing six months of treatment will be summarized using descriptive statistics. | 6 months | |
Secondary | Incidence of toxicity assessed according to the National Institute of Health Common Terminology Criteria for Adverse Events (NIH CTCAE) version 4.0 | Type and grade of toxicity will be assessed on every schedule visit and recorded based on NIH CTCAE 4.0 grading system. Descriptive statistics will be used to summarized type and grade of toxicity. | Up to 5 years | |
Secondary | Quality of life (QOL) assessed by Functional Assessment of Cancer Therapy-General (FACT-G) questionnaires | The FACT-G questionnaires will be scored at baseline, 1 month, 3 months, and 6 months. The difference between two treatment groups will be analyzed with standard t-test at individual evaluation points. Average QOL scores during the study will be calculated and compared between the treatment groups. To estimate the magnitude of the difference between treatment groups, the standardized effect size and minimally important difference will be used. Repeated-measures mixed-effects models with random intercepts and slopes will be used to assess treatment differences in QOL measures over time. | Up to 6 months |
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