Intraocular Melanoma
Conditions
Keywords
ciliary body and choroid melanoma, medium/large size, iris melanoma, metastatic intraocular melanoma, recurrent intraocular melanoma, extraocular extension melanoma
Brief summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.
Detailed description
OBJECTIVES: Primary * To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation. Secondary * To determine the median progression-free survival of patients treated with this regimen. * To determine the overall survival of patients treated with this regimen. OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 8 weeks for 1 year.
Interventions
DRUGnab-paclitaxel
150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Sponsors
National Comprehensive Cancer Network
Celgene Corporation
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed evidence of metastatic/ unresectable uveal melanoma * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension and is ≥10 mm by spiral CT scan * 18 years or older * Eastern Cooperative Oncology Group(ECOG)performance status 0, or 1 * No known HIV or Hepatitis B or C * Patients with brain metastasis are eligible for entry into the study * Patients must have normal organ/marrow function as defined below: * Absolute neutrophil count ≥ 1.5 x 109/L * Platelets ≥ 100,000 x 109/L * Hemoglobin ≥ 9.0 gm/100 ml * Total bilirubin ≤ 1.5. In patients with Gilbert's disease the indirect bilirubin must be less than or equal to 4.0. * AST and ALT ≤ 2.5x upper limit of normal * Alkaline phosphatase ≤ 2.5x upper limit of normal, unless bone metastases is present in the absence of liver metastasis * Creatinine ≤ 1.8 mg/ml or calculated creatinine clearance \> 50 mg ml. * Calcium \<12 mg/dl when corrected for levels of serum albumen * Patients my have had up to one prior systemic therapy
Exclusion criteria
* Chemotherapy or radiotherapy within 4 weeks prior to entering the study or failure to recover from adverse events due to agents administered more than 4 weeks earlier. * May not be receiving any other simultaneous investigational agents * No prior malignancy except for adequately treated basal cell cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years. * Patients who have serious infections or other major uncontrolled medical illnesses. * Patients who have significant psychiatric illness who in the opinion of the principal investigator would prevent adequate informed consent or render therapy unsafe. * Patients who are pregnant. Female patients of child bearing potential must have a negative serum pregnancy test and use adequate contraception protection while on study. * Peripheral neuropathy of \> grade 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | up to 1 year following last treatment, for a total of approximately 5 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | up to 1 year following last treatment, for a total of approximately 5 years | Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel |
| Overall Survival | up to 1 year following last treatment, for a total of approximately 5 years | Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NAb-paclitaxel Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | NAb-paclitaxel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Overall Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by 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.
Time frame: up to 1 year following last treatment, for a total of approximately 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nab-paclitaxel | Overall Response Rate | 0 patients |
Secondary
Overall Survival
Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive.
Time frame: up to 1 year following last treatment, for a total of approximately 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nab-paclitaxel | Overall Survival | 6.1833 months | Standard Error 0.8369 |
Secondary
Progression-free Survival
Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel
Time frame: up to 1 year following last treatment, for a total of approximately 5 years
Population: all patients progressed at the time of first scan
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nab-paclitaxel | Progression-free Survival | 6.2 months |