Malignant Melanoma of Skin Stage IIIPhase 2NCT02142335
Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma
A Phase 2 study testing Rituxan in people with Malignant Melanoma of Skin Stage III and Metastatic Melanoma, run by California Cancer Assocaties for Research & Excellence at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma of Skin Stage III, Metastatic Melanoma
- What is being tested?
- Rituxan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 26Show fewer
- 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.
Who cannot join
- Life expectancy less than 3 months
- Untreated brain metastasis
- Previous treatment with Abraxane containing regimen
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Cancer Associates For Research,cCARE
Encinitas, California, 92024
Edward F McClay, M.D., 760-452-3340, emcclay@pacificoncology.com
Beth c Kimball, RN, OCN, 760-452-3909, bkimball@pacificoncology.com
About this study
Official title: 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
Read the 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
- Being tested
- Rituxan
- Keywords
- B-Raf, inoperable stage III melanoma, metastatic stage IV melanoma,
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituxanDrug
Also called Abraxane
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
| Study group | Role | What they receive |
|---|---|---|
| Rituxan/Abraxane | Experimental | This is a single arm study. All patients recieve treatment. Receives: Drug: Rituxan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline-12 weeks
Secondary outcomes (1)
Response rate as Percent change in diameter (mm) of target lesions
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Melanoma of Skin Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Cancer Assocaties for Research & Excellence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward F. McClay, M.D., California Cancer Assocaties for Research & Excellence
- Investigators
- Edward F. McClay, M.D., Principal investigator, California Cancer Assocaties for Research & Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142335
- Sponsor's protocol ID
- ML29065
- Other IDs
- 20132169
- Status last verified
- May 2014
- First submitted
- 25 Mar 2014
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of the Combination of Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma
- ClinicalTrials.gov ID
- NCT02142335
- Acronym / sponsor ID
- ML29065
- Keywords
- B-Raf, inoperable stage III melanoma, metastatic stage IV melanoma,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- California Cancer Assocaties for Research & ExcellenceUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituxan/Abraxane | Experimental | Drug: RituxanThis is a single arm study. All patients recieve treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients must have inoperable stage III and IV melanoma.
- 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.
- 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.
Key exclusion criteria (3 listed)
- Life expectancy less than 3 months
- Untreated brain metastasis
- Previous treatment with Abraxane containing regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituxanAlso: AbraxaneThe 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 | Drug | Rituxan/Abraxane |
Primary outcome
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
1 secondary outcome
Response rate as Percent change in diameter (mm) of target lesions
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- California Cancer Associates For Research and Excellence, ccare clinical trialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward F. McClay, M.D. principal investigator
California Cancer Assocaties for Research & Excellence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituxan in people with Malignant Melanoma of Skin Stage III and Metastatic Melanoma, run by California Cancer Assocaties for Research & Excellence at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward F McClay, MD (760-452-3340, emcclay@pacificoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response as determined by a Percent change (%) in the sum of the diameters of target lesions. (time frame: baseline-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.