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

May 16, 2014 updated by: Edward F. McClay, M.D., California Cancer Assocaties for Research & Excellence

A Phase II Trial of the Combination of Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92024
        • Recruiting
        • California Cancer Associates For Research,cCARE
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edward F. McClay, M.D.
        • Sub-Investigator:
          • Alberto Bessudo, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituxan/Abraxane
This is a single arm study. All patients recieve treatment.
Drug: 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 Names:
  • Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline-12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate as Percent change in diameter (mm) of target lesions
Time Frame: 2 years
Overall response rate ( complete response + Partial response) will be determined by the disappearance of lesions or a reduction of target lesions in short axis to <10mm (CR) + at least a 30% decrease in the sum of the longest diameters of the target lesions (PR).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Cancer Assocaties for Research & Excellence

Investigators

  • Principal Investigator: Edward F. McClay, M.D., California Cancer Assocaties for Research & Excellence

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29065
  • 20132169 (Other Identifier: WIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Melanoma

Clinical Trials on Rituxan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe