A Phase II Trial of the Combination of Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Rituxan
- Conditions
- Malignant Melanoma of Skin Stage III
- Sponsor
- California Cancer Assocaties for Research & Excellence
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Overall response as determined by a Percent change (%) in the sum of the diameters of target lesions.
- Last Updated
- 11 years ago
Overview
Brief Summary
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
Detailed Description
Rituxan and Abraxane are approved for the treatment of other cancers, but not for melanoma. Candidates for this study have melanoma that has spread to their lymph nodes or internal organs and that cannot be removed by a surgical procedure. The safety of this combination of drugs will also be looked at throughout this study. Rituxan will be administered IV at weeks 1 and 3 of each cycle. Abraxane will be administered IV weekly for 3 consecutive weeks. This is followed by 1 week of rest after which, the cycle is repeated. Following the second cycle, there will be a 4-week period of rest. Evaluation of response will occur on day 71 +/-3 days. If either disease stabilization or clear evidence of clinical response is observed two additional cycles of treatment will be administered. Lesions will be measured on the scan (CT or PET/CT), x-ray
Investigators
Edward F. McClay, M.D.
Principal Investigator
California Cancer Assocaties for Research & Excellence
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.
Exclusion Criteria
- •Life expectancy less than 3 months
- •Untreated brain metastasis
- •Previous treatment with Abraxane containing regimen
Arms & Interventions
Rituxan/Abraxane
This is a single arm study. All patients recieve treatment.
Intervention: Rituxan
Outcomes
Primary Outcomes
Overall response as determined by a Percent change (%) in the sum of the diameters of target lesions.
Time Frame: baseline-12 weeks
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
- Response rate as Percent change in diameter (mm) of target lesions(2 years)