MelanomaPhase 1NCT01603212
Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor
A Phase 1 study testing Vemurafenib, IL-2 and Interferon Alpha-2b in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Vemurafenib, IL-2 and Interferon Alpha-2b
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2013to 5 Jul 2017
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III skin or mucosal melanoma are eligible if they have BRAF mutation affecting the V600 site, as determined by a chemiluminescence immunoassay analyzer (CLIA)-certified assay. Mutation testing of archival tumor tissue is acceptable, or it may be performed on new biopsy. If a new biopsy is performed for testing, biopsy of a metastasis is preferred to biopsy of a primary tumor.
- Patients must have at least one bidimensionally measurable lesion. If this is a cutaneous lesion it must be at least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion, it must be clearly measurable > 20 mm with conventional techniques or > 10 mm with spiral CT scan. Bone lesions are not considered measurable.
- Phase I: Patients with prior therapy who do not have alternative treatment of higher priority will be eligible. Phase II: the patient may have been treated with cytotoxic drugs or targeted therapies for metastatic disease but not with IL-2, interferon and BRAF inhibitor drugs. Adjuvant interferon will be permitted. Prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity. Prior chemotherapy is permitted provided the patient has a 21 day wash out period and the patient has fully recovered from its toxicity.
- Patients between 18 years of age and 65 years of age with an Eastern Cooperative Oncology (ECOG) performance status of 0, 1 or 2 will be eligible.
- They should have normal blood counts with a white blood cell count (WBC) count of more than or equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3 and a platelet count of more than 100,000/mm^3 and have no impairment of renal function (serum creatinine less than 1.1 mg/dl for females and less than 1.4 mg/dl for males), hepatic function (serum bilirubin level of less than 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
- They should have no significant intercurrent illness such as an active infection associated with fever lasting more than 24 hours requiring antibiotics, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), active GI bleeding, myocardial disease with corrected QT interval (QTC) interval > 480 on baseline ECG or history of rheumatoid arthritis.
- Females of child-bearing potential (non-childbearing is defined as greater than one year post-menopausal or surgically sterilized) must use acceptable contraceptive methods( abstinence, intrauterine device, oral contraceptive or double barrier devices) and must have a negative serum or urine pregnancy test within 72 hours prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.
Who cannot join
- Patients with uveal melanoma.
- Patients with bone metastases only.
- Patients with brain metastases unless all of their metastatic brain lesions have been resected or treated with stereotactic radiotherapy with gamma rays and they are off corticosteroids. Patient should not have significant brain edema. Patients with spinal cord compression and leptomeningeal disease. No major surgery or radiation therapy within 21 days before starting treatment.
- Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (Ejection Fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients will be evaluated by the investigator or his designee.
- Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of forced expiratory volume at one second (FEV1) to less than 65 % of predicted normal values.
- Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
- Patients who are unable to return for follow-up visits as required by this study.
- Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 3 years and uncertainty about the histological nature of the metastatic lesions. Cases with other types of malignancies should be reviewed and decided by the PI of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Systemic Therapy of Metastatic Melanoma With Multidrug Regimen Including Interferon, Interleukin-2 and BRAF Inhibitor
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied.
The goal of Phase II is to learn if this study drug combination can help to control advanced or metastatic melanoma.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 4 groups of 6 participants will be enrolled in the Phase I portion of the study and up to 53 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of vemurafenib and aldesleukin you receive will depend on when you joined this study. The first group of participants will receive the lowest dose levels of vemurafenib and aldesleukin. Each new group will receive a higher dose of vemurafenib or aldesleukin than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable doses of vemurafenib and aldesleukin are found.
If you are enrolled in the Phase II portion, you will receive vemurafenib and aldesleukin at the highest doses that were tolerated in the Phase I portion.
All participants will receive the same dose level interferon alfa-2b.
Study Drug Administration:
Each study cycle is 21 days.
You will take vemurafenib by mouth twice a day (1 time in the morning and 1 time in the evening) every day of each study cycle. Vemurafenib can be taken with or without food. If you miss a scheduled dose of vemurafenib, do not try to "make up" the dose by taking 2 doses at the next scheduled dosing time. Continue taking the study drug as scheduled.
You will receive aldesleukin by vein over 96 hours on Days 1-4 of each study cycle.
To receive aldesleukin, you will have a central venous catheter (CVC) inserted, if you do not already have one. A CVC is a sterile flexible tube that will be place into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
You will receive interferon alfa-2b as an injection under your skin on Days 1-5 of each study cycle.
Supportive Drugs:
You will be given other drugs to help lower the risk of side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.
Study Visits:
The following tests and procedures will be performed:
On Day 1 (+/- 3 days) of each cycle:
- Your performance status will be recorded.
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may have had.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
- You will have an EKG.
Your skin will be checked for non-melanoma skin cancers on Day 1 of Cycle 1 (+/- 3 days) and then every 3 cycles.
Blood (about 1 teaspoon) will be drawn for routine tests on Days 1, 8, and 15 of each cycle. On Day 1 of each cycle, some of this blood will be used to check your liver and kidney function.
At the end of each cycle (Day 21), you will have a physical exam, including measurement of your weight. Any tumor that can be felt with the hands will be measured with measuring tape during the physical exam to see if it has changed size.
On Day 21 (+/- 7 days) of every 2 cycles, you will have a chest x-ray and a CT or MRI scan to check the status of the disease.
Anytime the doctor thinks it is needed, photos of any skin lesions you have will be taken. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face.
Length of Study:
You may take the study drug combination for as long as the doctor thinks you are benefitting. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.
End-of-Treatment Visit
Within 14 days after you stop taking the study drug combination, the following tests and procedures will be performed:
- Your performance status will be recorded.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any drugs you may be taking and any side effects you may have had. vBlood (about 2 tablespoons) will be drawn for routine tests.
° If the doctor thinks it is needed, you will have a CT or MRI scan.
Follow-Up Every 3 months for up to 3 years, you will be contacted by phone or during a clinic visit to see how you are doing. The phone call should last about 5 minutes.
This is an investigational study. Vemurafenib, interferon alfa-2b, and Aldesleukin are FDA approved and commercially available to treat metastatic cancer. Giving these drugs in combination is investigational. The study doctor will tell you how the study drugs are designed to work.
Up to 71 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Melanoma
- Being tested
- Vemurafenib, IL-2, Interferon Alpha-2b
- Keywords
- Melanoma, Metastatic melanoma, Advanced melanoma, Vemurafenib, PLX4032, RO5185426, IL-2, Interleukin-2, Aldesleukin, Proleukin, Interferon Alfa-2b, Intron A
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VemurafenibDrug
Also called PLX4032, RO5185426
Phase I Starting dose: 720 mg by mouth twice a day for a 21 day cycle.
Phase II Starting dose: Maximum tolerated dose (MTD) from Phase I.
IL-2Drug
Also called Interleukin-2, Aldesleukin, Proleukin
Phase I Starting Dose: 7 million IU/m2 by vein on Days 2 - 5 of a 21 day cycle.
Phase II Starting Dose: Maximum tolerated dose (MTD) from Phase I.
Interferon Alpha-2bDrug
Also called Intron A
5 million U/m2 subcutaneously on Days 1 - 5 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Vemurafenib + IL-2 + Interferon Alfa-2b | Experimental | Starting dose of Vemurafenib 720 mg by mouth twice daily. Three dose levels of Vemurafenib evaluated in combination with interferon and IL-2. These doses are 480 mg, 720 mg and 960 mg. IL-2 given by continuous venous infusion at starting IL-2 dose of 7 million IU/m2 daily for 4 days (total of 96 hours, days 2-5) starting day 2. IL-2 dose levels are 5MU/m2/day, 7MU/m2/day and 9MU/m2 day. Doses of interferon remain constant at 5 MU/m2 subcutaneously daily for 5 days starting Day 1. Receives: Drug: Vemurafenib; Drug: IL-2; Drug: Interferon Alpha-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Vemurafenib in Combination With Interferon Alpha 2b and IL-2
Maximum tolerated dose (MTD) defined as highest dose studied in which incidence of dose limiting toxicity (DLT) was less than 33%. DLT defined as any grade 3 or 4 non-hematological toxicity excluding manageable N/V, diarrhea and fatigue and manageable/replaceable grade 3 or 4 electrolyte abnormalities, and appearance of new squamous cell skin cancers. Toxicity that may result in delaying next course for more than 3 weeks. Any grade 4 neutropenia more than 7 days duration or Grade 4 thrombocytopenia lasting more than 7 days.
Measured: 21 days
Progression-Free Survival (PFS)
Progression-free survival estimated using the method of Kaplan-Meier. It will be determined from the start of the study until disease progression or death, whichever is first.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study start18 Jul 2013
- Primary completion5 Jul 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodabe N. Amaria, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603212
- Sponsor's protocol ID
- 2011-0847
- Other IDs
- NCI-2012-02759
- Status last verified
- May 2019
- First submitted
- 18 May 2012
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Therapy of Metastatic Melanoma With Multidrug Regimen Including Interferon, Interleukin-2 and BRAF Inhibitor
- ClinicalTrials.gov ID
- NCT01603212
- Acronym / sponsor ID
- 2011-0847
- Conditions
- Melanoma
- Keywords
- Melanoma, Metastatic melanoma, Advanced melanoma, Vemurafenib, PLX4032, RO5185426, IL-2, Interleukin-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Jul 2013 (actual)
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 22 May 2012 (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 goal of the Phase I part of this clinical research study is to find the highest tolerable dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied.
The goal of Phase II is to learn if this study drug combination can help to control advanced or metastatic melanoma.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 4 groups of 6 participants will be enrolled in the Phase I portion of the study and up to 53 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of vemurafenib and aldesleukin you receive will depend on when you joined this study. The first group of participants will receive the lowest dose levels of vemurafenib and aldesleukin. Each new group will receive a higher dose of vemurafenib or aldesleukin than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable doses of vemurafenib and aldesleukin are found.
If you are enrolled in the Phase II portion, you will receive vemurafenib and aldesleukin at the highest doses that were tolerated in the Phase I portion.
All participants will receive the same dose level interferon alfa-2b.
Study Drug Administration:
Each study cycle is 21 days.
You will take vemurafenib by mouth twice a day (1 time in the morning and 1 time in the evening) every day of each study cycle. Vemurafenib can be taken with or without food. If you miss a scheduled dose of vemurafenib, do not try to "make up" the dose by taking 2 doses at the next scheduled dosing time. Continue taking the study drug as scheduled.
You will receive aldesleukin by vein over 96 hours on Days 1-4 of each study cycle.
To receive aldesleukin, you will have a central venous catheter (CVC) inserted, if you do not already have one. A CVC is a sterile flexible tube that will be place into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
You will receive interferon alfa-2b as an injection under your skin on Days 1-5 of each study cycle.
Supportive Drugs:
You will be given other drugs to help lower the risk of side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.
Study Visits:
The following tests and procedures will be performed:
On Day 1 (+/- 3 days) of each cycle:
- Your performance status will be recorded.
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may have had.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
- You will have an EKG.
Your skin will be checked for non-melanoma skin cancers on Day 1 of Cycle 1 (+/- 3 days) and then every 3 cycles.
Blood (about 1 teaspoon) will be drawn for routine tests on Days 1, 8, and 15 of each cycle. On Day 1 of each cycle, some of this blood will be used to check your liver and kidney function.
At the end of each cycle (Day 21), you will have a physical exam, including measurement of your weight. Any tumor that can be felt with the hands will be measured with measuring tape during the physical exam to see if it has changed size.
On Day 21 (+/- 7 days) of every 2 cycles, you will have a chest x-ray and a CT or MRI scan to check the status of the disease.
Anytime the doctor thinks it is needed, photos of any skin lesions you have will be taken. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face.
Length of Study:
You may take the study drug combination for as long as the doctor thinks you are benefitting. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.
End-of-Treatment Visit
Within 14 days after you stop taking the study drug combination, the following tests and procedures will be performed:
- Your performance status will be recorded.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any drugs you may be taking and any side effects you may have had. vBlood (about 2 tablespoons) will be drawn for routine tests.
° If the doctor thinks it is needed, you will have a CT or MRI scan.
Follow-Up Every 3 months for up to 3 years, you will be contacted by phone or during a clinic visit to see how you are doing. The phone call should last about 5 minutes.
This is an investigational study. Vemurafenib, interferon alfa-2b, and Aldesleukin are FDA approved and commercially available to treat metastatic cancer. Giving these drugs in combination is investigational. The study doctor will tell you how the study drugs are designed to work.
Up to 71 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vemurafenib + IL-2 + Interferon Alfa-2b | Experimental | Drug: Vemurafenib, Drug: IL-2, Drug: Interferon Alpha-2bStarting dose of Vemurafenib 720 mg by mouth twice daily. Three dose levels of Vemurafenib evaluated in combination with interferon and IL-2. These doses are 480 mg, 720 mg and 960 mg. IL-2 given by continuous venous infusion at starting IL-2 dose of 7 million IU/m2 daily for 4 days (total of 96 hours, days 2-5) starting day 2. IL-2 dose levels are 5MU/m2/day, 7MU/m2/day and 9MU/m2 day. Doses of interferon remain constant at 5 MU/m2 subcutaneously daily for 5 days starting Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III skin or mucosal melanoma are eligible if they have BRAF mutation affecting the V600 site, as determined by a chemiluminescence immunoassay analyzer (CLIA)-certified assay. Mutation testing of archival tumor tissue is acceptable, or it may be performed on new biopsy. If a new biopsy is performed for testing, biopsy of a metastasis is preferred to biopsy of a primary tumor.
- Patients must have at least one bidimensionally measurable lesion. If this is a cutaneous lesion it must be at least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion, it must be clearly measurable > 20 mm with conventional techniques or > 10 mm with spiral CT scan. Bone lesions are not considered measurable.
- Phase I: Patients with prior therapy who do not have alternative treatment of higher priority will be eligible. Phase II: the patient may have been treated with cytotoxic drugs or targeted therapies for metastatic disease but not with IL-2, interferon and BRAF inhibitor drugs. Adjuvant interferon will be permitted. Prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity. Prior chemotherapy is permitted provided the patient has a 21 day wash out period and the patient has fully recovered from its toxicity.
- Patients between 18 years of age and 65 years of age with an Eastern Cooperative Oncology (ECOG) performance status of 0, 1 or 2 will be eligible.
- They should have normal blood counts with a white blood cell count (WBC) count of more than or equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3 and a platelet count of more than 100,000/mm^3 and have no impairment of renal function (serum creatinine less than 1.1 mg/dl for females and less than 1.4 mg/dl for males), hepatic function (serum bilirubin level of less than 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
Key exclusion criteria (8 listed)
- Patients with uveal melanoma.
- Patients with bone metastases only.
- Patients with brain metastases unless all of their metastatic brain lesions have been resected or treated with stereotactic radiotherapy with gamma rays and they are off corticosteroids. Patient should not have significant brain edema. Patients with spinal cord compression and leptomeningeal disease. No major surgery or radiation therapy within 21 days before starting treatment.
- Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (Ejection Fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients will be evaluated by the investigator or his designee.
- Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of forced expiratory volume at one second (FEV1) to less than 65 % of predicted normal values.
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 |
|---|---|---|
| VemurafenibAlso: PLX4032, RO5185426Phase I Starting dose: 720 mg by mouth twice a day for a 21 day cycle. Phase II Starting dose: Maximum tolerated dose (MTD) from Phase I. | Drug | Vemurafenib + IL-2 + Interferon Alfa-2b |
| IL-2Also: Interleukin-2, Aldesleukin, ProleukinPhase I Starting Dose: 7 million IU/m2 by vein on Days 2 - 5 of a 21 day cycle. Phase II Starting Dose: Maximum tolerated dose (MTD) from Phase I. | Drug | Vemurafenib + IL-2 + Interferon Alfa-2b |
| Interferon Alpha-2bAlso: Intron A5 million U/m2 subcutaneously on Days 1 - 5 of a 21 day cycle. | Drug | Vemurafenib + IL-2 + Interferon Alfa-2b |
Primary outcome
Maximum Tolerated Dose (MTD) of Vemurafenib in Combination With Interferon Alpha 2b and IL-2
Time frame: 21 days
Maximum tolerated dose (MTD) defined as highest dose studied in which incidence of dose limiting toxicity (DLT) was less than 33%. DLT defined as any grade 3 or 4 non-hematological toxicity excluding manageable N/V, diarrhea and fatigue and manageable/replaceable grade 3 or 4 electrolyte abnormalities, and appearance of new squamous cell skin cancers. Toxicity that may result in delaying next course for more than 3 weeks. Any grade 4 neutropenia more than 7 days duration or Grade 4 thrombocytopenia lasting more than 7 days.
Progression-Free Survival (PFS)
Time frame: 6 months
Progression-free survival estimated using the method of Kaplan-Meier. It will be determined from the start of the study until disease progression or death, whichever is first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Rodabe N. Amaria, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vemurafenib, IL-2 and Interferon Alpha-2b in people with Melanoma, run by M.D. Anderson Cancer Center 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 21 May 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Vemurafenib in Combination With Interferon Alpha 2b and IL-2 (time frame: 21 days). The study lists 2 primary outcomes in all. 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 21 May 2019.