Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma

NCT02142335 | Unknown Phase 2

• 2 other identifiers: ML2906520132169
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Melanoma of Skin Stage III; Metastatic Melanoma

Keywords

B-Raf, inoperable stage III melanoma, metastatic stage IV melanoma,

Outcome Measures

Primary Outcomes (1)

• Overall response as determined by a Percent change (%) in the sum of the diameters of target lesions.

  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

  baseline-12 weeks

Secondary Outcomes (1)

• Response rate as Percent change in diameter (mm) of target lesions

  2 years

Study Arms (1)

Rituxan/Abraxane

EXPERIMENTAL

This is a single arm study. All patients recieve treatment.

Drug: Rituxan

Interventions

Rituxan DRUG

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

Also known as: Abraxane

Rituxan/Abraxane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• Life expectancy less than 3 months
• Untreated brain metastasis
• Previous treatment with Abraxane containing regimen

Sponsors & Collaborators

• California Cancer Assocaties for Research & Excellence: lead

Study Sites (1)

California Cancer Associates For Research,cCARE

Encinitas, California, 92024, United States

RECRUITING

Related Links

• California Cancer Associates For Research and Excellence, ccare clinical trials

MeSH Terms

Conditions

Melanoma

Interventions

Rituximab; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins

Study Officials

• Edward F. McClay, M.D.

  California Cancer Assocaties for Research & Excellence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward F McClay, MD

CONTACT

760-452-3340; emcclay@pacificoncology.com

Beth Kimball, OCN, RN

CONTACT

760-452-3909; bkmball@pacificoncology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: May 20, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (1)