Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT02142335
Eligibility Criteria:
Inclusion Criteria:
* Patients must have inoperable stage III and IV melanoma.
Patients will be included in the trial based on the following criteria:
Patients previously treated with no more than 1 non-abraxane containing chemotherapy regimen or patients with the B-Raf mutation, who have received vemurafenib or the combination of Dabrafinib and trametinib (or similar compound on clinical trial) and progressed, who have documented surgically inoperable stage III or IV metastatic melanoma on pathologic examination of tissue. Previous treatment with immunotherapy is allowed. Patients who have been treated with either immunotherapy or chemotherapy must have be either 4 weeks from their last treatment or have fully recovered from all previous treatment.
Measurable or evaluable non-CNS disease required as defined:
* Uni-dimensionally measurable lesion as determined by physical exam, X-ray, CT scan, MRI, or other radiographic procedure.
* Lesion that can be seen on a radiologic test but is not uni-dimensionally measurable
* Previously irradiated lesion allowed only with documentation of progression if no other metastatic site present.
No active brain metastases Patients with previously treated brain metastases that have responded to therapy will be allowed on study assuming there is measurable disease outside of the CNS. Active therapy for the CNS disease must be completed a minimum of 3 weeks for chemotherapy and 6 weeks for radiation therapy (prior to enrollment on this study).
Prior/ Concurrent therapy
Biologic therapy No concurrent biological therapy with the exception of growth factors for anemia, neutropenia or thrombocytopenia.
Chemotherapy No greater than 1 previous non-abraxane containing chemotherapy treatment allowed
Radiotherapy At least 6 weeks since completion of radiotherapy
Patient characteristics Age and ability to give informed consent Patients must be 18 years of age or older. Patients must have the ability to give informed consent.
Performance status ECOG 0-2 Life expectancy of at least 3 months
General Medical Concerns:
* Normal organ function, except if abnormal due to tumor involvement.
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment.
* Subject has provided written informed consent.
Rituximab-Specific Concerns:
* ANC: \> 1200/mm3
* Platelets: \> 100,000/mm3
* Hemoglobin: \> 9 gm/dL
* Adequate renal function as indicated by serum creatinine measurement \< 1.5 x the upper limit of normal or GFR \> 50 ml/min.
* Adequate liver function, as indicated by bilirubin \< 3.0
* AST or ALT \<2x Upper Limit of Normal unless related to primary disease.
* AST or ALT \<5x Upper limit of Normal if evidence of liver metastasis.
Exclusion Criteria:
* Life expectancy less than 3 months
Untreated brain metastasis
Previous treatment with Abraxane containing regimen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02142335
Study Brief:
Protocol Section:
NCT02142335