Clinical trial · Interventional
Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma
A Phase II Trial of the Combination of Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma
NCT02142335CI-TRIAL-00014589unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to test an experimental combination of drugs to determine if they can cause shrinkage or even complete disappearance of your melanoma. The two drugs being tested in combination are Rituxan and Abraxane
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma of Skin Stage III | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituxan | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituxan/Abraxane
- description
- This is a single arm study. All patients recieve treatment.
- interventionNames
- Drug: Rituxan
Primary outcomes (1)
- measure
- Overall response as determined by a Percent change (%) in the sum of the diameters of target lesions.
- timeFrame
- baseline-12 weeks
- description
- Evaluation of response (Progression Free and overall survival will be determined by measuring and recording the largest diameter of a lesion. Add these values together and record the value as the sum of the largest diameters.The percent change will be obtained according to the following formula: Percent change = sum of the longest diameter at 12weeks X 100 Sum of the longest diameters pre treatment
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.