Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Ipilimumab + Imatinib for Cancer
Phase 1
Waitlist Available
Led By David S Hong
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients MUST have recovered from all treatment related toxicities to grade 1 National Center Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version [v] 4.0) in severity
For expansion cohorts, patients must have metastatic or unresectable gastrointestinal stromal tumor (GIST), melanoma, or uncategorized tumors with tumor biopsies that are positive for c-KIT mutations by polymerase chain reaction (PCR) or immunohistochemistry (IHC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dosage of two drugs, ipilimumab and imatinib mesylate, to treat patients with solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that have spread or can't be surgically removed. Participants must have recovered from previous treatments, not have certain mutations, and meet specific health criteria like adequate organ function. Pregnant women, those with HIV/hepatitis B/C, bowel risks, autoimmune diseases or on conflicting medications are excluded.Check my eligibility
What is being tested?
The trial tests the combination of ipilimumab (an immune system booster) and imatinib mesylate (a cell growth blocker) to see if they're more effective together against cancer. It's a phase I study focusing on side effects and finding the best dose for patients with solid tumors including melanoma and gastrointestinal stromal tumors.See study design
What are the potential side effects?
Potential side effects include typical reactions to immunotherapy such as fatigue, diarrhea, skin rash, liver inflammation; and for imatinib mesylate: fluid retention, muscle cramps, bleeding problems. The exact side effects will be studied in this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have recovered from side effects of previous treatments to a mild level.
Select...
My cancer is advanced and cannot be removed by surgery, and tests show c-KIT mutations.
Select...
My cancer is confirmed to be advanced and cannot be removed by surgery.
Select...
I can stay within 2 hours drive of MD Anderson for my treatment.
Select...
My cancer does not have specific mutations in exon 13, 14, 17, or 18.
Select...
I can do most activities by myself.
Select...
I have been diagnosed with a specific type of brain tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose (MTD)
Side effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ipilimumab, imatinib mesylate)Experimental Treatment2 Interventions
Patients receive ipilimumab IV over 90 minutes on day 1 and imatinib mesylate PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
FDA approved
Ipilimumab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,148 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,421 Total Patients Enrolled
David S HongPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
212 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from side effects of previous treatments to a mild level.My cancer is advanced and cannot be removed by surgery, and tests show c-KIT mutations.I have had serious gut issues like diverticulitis or blockages.My cancer is confirmed to be advanced and cannot be removed by surgery.Your platelet count is higher than 100,000 per microliter.I can stay within 2 hours drive of MD Anderson for my treatment.I agree to go to MD Anderson's emergency center if needed while on Ipilimumab.Your blood creatinine level is below 2.0 mg/dL.My cancer does not have specific mutations in exon 13, 14, 17, or 18.I can do most activities by myself.Your white blood cell count is higher than 3,000 cells per microliter.Your liver enzymes (AST and ALT) are not too high, unless you have liver involvement, in which case they can be a little higher.I have been diagnosed with HIV, hepatitis B, or hepatitis C.I finished my last cancer treatment at least 4 weeks ago.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have been diagnosed with a specific type of brain tumor.Your MRI scan shows clear signs that your tumor is growing.I have not received any live vaccines for infectious diseases one month before or after receiving ipilimumab.Your absolute neutrophil count is higher than 1,500 per microliter.I am not currently on treatments like IL-2, interferon, chemotherapy, or long-term steroids.I do not have inflammatory bowel disease or autoimmune disorders like rheumatoid arthritis.Your total bilirubin level is less than or equal to 2.0 mg/dL, unless you have Gilbert's syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ipilimumab, imatinib mesylate)
Awards:
This trial has 3 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have enrolled in this clinical exploration?
"Affirmative. Clinicaltrials.gov data indicates that, since its initial posting on February 19th 2013, this trial is still actively searching for participants from one specified location. The total number of individuals requested is 96 patients."
Answered by AI
Can individuals still join this clinical experiment?
"Based on the information exhibited on clinicaltrials.gov, this trial is in progress and seeking participants. This research project was first made public on February 19th 2013 before being updated most recently August 1st 2022."
Answered by AI
Has Ipilimumab been previously investigated in other research projects?
"Presently, there are 368 different clinical trials being conducted on ipilimumab. Of those studies, 53 of them have reached the third phase of testing and Pittsburgh, PA is a primary hub for this research. Globally though, the treatment has been tested in 22168 separate locations."
Answered by AI
Does Ipilimumab pose any risks to human health?
"Given that this is a Phase 1 trial, Ipilimumab has been rated at a 1 for safety by our team here at Power. This is because only minimal data exists to support its efficacy and safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger