Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma
NCT ID: NCT02142335
Last Updated: 2014-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
17 participants
INTERVENTIONAL
2014-03-31
2016-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituxan/Abraxane
This is a single arm study. All patients recieve treatment.
Rituxan
The dose of Rituxan is 375 mg/m2¬ administered as an IV infusion during weeks 1 \& 3 (days 1 \& 15)Abraxane will be administered at a fixed dose of 100 mg/m2 as an IV infusion weekly for three weeks in a row followed by one week of rest
Interventions
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Rituxan
The dose of Rituxan is 375 mg/m2¬ administered as an IV infusion during weeks 1 \& 3 (days 1 \& 15)Abraxane will be administered at a fixed dose of 100 mg/m2 as an IV infusion weekly for three weeks in a row followed by one week of rest
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Untreated brain metastasis
Previous treatment with Abraxane containing regimen
18 Years
ALL
No
Sponsors
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California Cancer Assocaties for Research & Excellence
OTHER
Responsible Party
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Edward F. McClay, M.D.
Principal Investigator
Principal Investigators
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Edward F. McClay, M.D.
Role: PRINCIPAL_INVESTIGATOR
California Cancer Assocaties for Research & Excellence
Locations
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California Cancer Associates For Research,cCARE
Encinitas, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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California Cancer Associates For Research and Excellence, ccare clinical trials
Other Identifiers
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20132169
Identifier Type: OTHER
Identifier Source: secondary_id
ML29065
Identifier Type: -
Identifier Source: org_study_id
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