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Tyrosine Kinase Inhibitor
Nilotinib + Paclitaxel for Rare Cancers
Phase 2
Recruiting
Led By Alice P Chen, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis
- Epithelial tumors of major salivary glands
Must not have
-- No history of intracranial hemorrhage or spinal cord hemorrhage
-- No metastases to brain stem, midbrain, pons, medulla, or cerebellum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if nilotinib and paclitaxel will help people with rare cancers. People with rare, advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists, may be eligible. The drugs are given in 28-day cycles. Nilotinib is a capsule taken by mouth twice a day. Paclitaxel will be given intravenously by peripheral line or central line once a week for the first 3 weeks of each cycle.
Who is the study for?
Adults aged 18+ with rare, advanced cancers that have worsened after standard treatment or for which no effective therapy exists. Participants must be in good health otherwise, with proper organ and marrow function, and not pregnant or breastfeeding. They should agree to use contraception during the trial and for some time after.
What is being tested?
The trial is testing a combination of two drugs—Nilotinib (oral capsule) and Paclitaxel (IV infusion)—to see if they can shrink or halt the growth of rare cancers. The drugs are given in cycles lasting 28 days, with close monitoring through tests and scans.
What are the potential side effects?
Possible side effects include tiredness, digestive issues like nausea or diarrhea, blood cell count changes leading to increased infection risk, heart problems due to abnormal rhythms, nerve damage causing numbness or tingling sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of penile cancer known as squamous cell carcinoma.
Select...
I have a tumor in my salivary gland.
Select...
I have peritoneal mesothelioma.
Select...
My cancer is a type of squamous cell in the urinary or genital area.
Select...
My kidney function, measured by creatinine or clearance, is within the required range.
Select...
I have gallbladder cancer.
Select...
I haven't had any cancer treatment since my tumor sample was taken.
Select...
I have been diagnosed with Merkel cell carcinoma.
Select...
I have been diagnosed with a malignant giant cell tumor.
Select...
My kidney function, measured by creatinine or clearance, is within the required range.
Select...
My cancer is a type of transitional cell carcinoma, but not from the kidney, bladder, or related areas.
Select...
I have basal cell carcinoma.
Select...
My cancer is in the bile ducts outside the liver.
Select...
I have fibromixoma or low-grade mucinous adenocarcinoma of the appendix or ovary.
Select...
My lung cancer is of the sarcomatoid type.
Select...
I have been diagnosed with uterine leiomyosarcoma.
Select...
I have been diagnosed with endometrial carcinosarcoma.
Select...
I have an adrenal cortical tumor.
Select...
My cancer is a type of adenocarcinoma in the urinary system, not including prostate cancer.
Select...
I have been diagnosed with a malignant pheochromocytoma.
Select...
My condition is either apocrine tumors or Extramammary Paget's Disease.
Select...
My cancer originates from the salivary glands and could be in areas like the head, neck, lung, or breast.
Select...
My ovarian cancer is of the clear cell type.
Select...
I have been diagnosed with angiosarcoma.
Select...
I have been diagnosed with a PEComa.
Select...
I have been diagnosed with thymic carcinoma.
Select...
I have been diagnosed with sarcoma in my bones or soft tissues.
Select...
My cervical cancer is the clear cell type.
Select...
I have a trophoblastic tumor.
Select...
I have a tumor related to my nerve sheath or NF1.
Select...
I have lymphoma.
Select...
My pancreatic cancer is a rare type, like acinar, mucinous, or serous.
Select...
My prostate cancer has changed into a more aggressive type known as small-cell.
Select...
I have a cancer that started in my tooth or jaw area.
Select...
I have a specific type of lung cancer known as bronchoalveolar carcinoma.
Select...
My cancer is a specific type called spindle cell carcinoma located in my kidney, pelvis, or ureter.
Select...
My cancer is a type of neuroendocrine tumor found in the lung.
Select...
My cancer originates from the pituitary, thyroid, parathyroid gland, or adrenal cortex.
Select...
My cancer is located in the nasal area or sinuses.
Select...
I have been diagnosed with chordoma.
Select...
I have a desmoid tumor.
Select...
I have been diagnosed with adenoid cystic carcinoma.
Select...
My breast cancer is metaplastic.
Select...
My cancer is a type called clear cell endometrial.
Select...
My cancer is a high-grade neuroendocrine carcinoma.
Select...
I have been diagnosed with gestational trophoblastic disease.
Select...
My condition is small cell carcinoma of the ovary, hypercalcemic type.
Select...
My kidney cancer is of the papillary type.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My rare solid tumor cancer has not responded to standard treatments.
Select...
My cancer is a type that started in the digestive system and is not well-defined.
Select...
My cancer is a type of adenocarcinoma located in the small intestine.
Select...
My cancer is a type of squamous cell carcinoma located in the digestive system.
Select...
I have cancer in the bile ducts inside my liver.
Select...
My ovarian cancer is not of the epithelial type.
Select...
My cancer originates from testicular cells or germ cells outside the gonads.
Select...
I have a pancreatic neuroendocrine tumor.
Select...
I have been diagnosed with anal cancer.
Select...
I have been diagnosed with pleural mesothelioma.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with vulvar cancer.
Select...
My cancer's origin is unknown.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never had bleeding in my brain or spinal cord.
Select...
My cancer has not spread to specific parts of my brain.
Select...
My cancer can be measured or seen outside the brain and spinal cord.
Select...
I do not have any serious illnesses that are not being treated.
Select...
I am not pregnant or breastfeeding.
Select...
My heart's electrical activity (QTcF interval) is normal and I don't have congenital long QT syndrome.
Select...
I have moderate to severe numbness, tingling, or muscle weakness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Nilotinib will be administered at 300 mg orally BID; Paclitaxel will be administered IV at 80 mg/m2 on Days 1, 8, and 15 in 28-day cycles.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,024,314 Total Patients Enrolled
3 Trials studying Tumors
925 Patients Enrolled for Tumors
Alice P Chen, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
3,749 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of penile cancer known as squamous cell carcinoma.I have never had bleeding in my brain or spinal cord.I have a tumor in my salivary gland.I have peritoneal mesothelioma.My organ and bone marrow functions are normal.My cancer is a type of squamous cell in the urinary or genital area.My cancer has not spread to specific parts of my brain.You are currently taking part in another research study.I haven't had brain surgery or a brain biopsy in the last 28 days.My kidney function, measured by creatinine or clearance, is within the required range.I finished my major cancer treatments at least 3 weeks ago and have recovered from the side effects.I have gallbladder cancer.You have had an allergic reaction to drugs similar to the ones being used in the study.I haven't had any cancer treatment since my tumor sample was taken.I have been diagnosed with Merkel cell carcinoma.I have been diagnosed with a malignant giant cell tumor.My kidney function, measured by creatinine or clearance, is within the required range.You have enough white blood cells called neutrophils.My cancer is a type of transitional cell carcinoma, but not from the kidney, bladder, or related areas.My cancer is a rare type not commonly categorized.I have basal cell carcinoma.My cancer is in the bile ducts outside the liver.My rare solid tumor has grown despite treatment, or there are no standard treatments for it.My tumor type is on the rare tumor eligibility list.I have fibromixoma or low-grade mucinous adenocarcinoma of the appendix or ovary.My lung cancer is of the sarcomatoid type.I am HIV positive, on treatment, and my viral load is undetectable.I have been diagnosed with uterine leiomyosarcoma.I have been diagnosed with endometrial carcinosarcoma.I have an adrenal cortical tumor.My cancer is a type of adenocarcinoma in the urinary system, not including prostate cancer.It's been over 4 weeks since my last brain radiation and 2 weeks since I stopped taking corticosteroids.My condition is either apocrine tumors or Extramammary Paget's Disease.I have brain involvement with my cancer but no symptoms, and meet specific health criteria.My cancer can be measured or seen outside the brain and spinal cord.I haven't had any brain radiation in the last 28 days.I agree to use effective birth control during and for 3 months after the study.I do not have any serious illnesses that are not being treated.My cancer originates from the salivary glands and could be in areas like the head, neck, lung, or breast.Your liver function test results are within the normal range, or slightly elevated if you have liver metastases.I have been diagnosed with a malignant pheochromocytoma.Your bilirubin level cannot be more than 1.5 times the highest normal value for the lab where you are being treated.My brain scans improved after CNS therapy with no worsening before this study's screening.You must have a disease that can be measured and evaluated by doctors.I have brain metastases but no symptoms after treatment.I am not pregnant or breastfeeding.My ovarian cancer is of the clear cell type.I have been diagnosed with angiosarcoma.I have been diagnosed with a PEComa.I have been diagnosed with thymic carcinoma.I have been diagnosed with sarcoma in my bones or soft tissues.I have been diagnosed with esthesioneuroblastoma.My cervical cancer is the clear cell type.I have a trophoblastic tumor.I have a tumor related to my nerve sheath or NF1.I have lymphoma.My pancreatic cancer is a rare type, like acinar, mucinous, or serous.I am not on dexamethasone for brain disease but can be on stable anticonvulsants.My prostate cancer has changed into a more aggressive type known as small-cell.I have a cancer that started in my tooth or jaw area.I have a specific type of lung cancer known as bronchoalveolar carcinoma.My cancer is a specific type called spindle cell carcinoma located in my kidney, pelvis, or ureter.My cancer is a type of neuroendocrine tumor found in the lung.My cancer originates from the pituitary, thyroid, parathyroid gland, or adrenal cortex.My cancer is located in the nasal area or sinuses.I have been diagnosed with paraganglioma.I have been diagnosed with chordoma.I have a desmoid tumor.I have been diagnosed with adenoid cystic carcinoma.My breast cancer is metaplastic.My cancer is a type called clear cell endometrial.My cancer is a high-grade neuroendocrine carcinoma.I have been diagnosed with gestational trophoblastic disease.My condition is small cell carcinoma of the ovary, hypercalcemic type.My kidney cancer is of the papillary type.My heart's electrical activity (QTcF interval) is normal and I don't have congenital long QT syndrome.I have moderate to severe numbness, tingling, or muscle weakness.I can take care of myself but might not be able to do heavy physical work.You have enough platelets in your blood, at least 100,000 per microliter.My rare solid tumor cancer has not responded to standard treatments.My cancer is a type that started in the digestive system and is not well-defined.My cancer is a type of adenocarcinoma located in the small intestine.My cancer is a type of squamous cell carcinoma located in the digestive system.I have cancer in the bile ducts inside my liver.My ovarian cancer is not of the epithelial type.My cancer originates from testicular cells or germ cells outside the gonads.I have a pancreatic neuroendocrine tumor.I have been diagnosed with a gastrointestinal stromal tumor.I have been diagnosed with anal cancer.I have been diagnosed with pleural mesothelioma.I do not have brain cancer or symptoms from cancer spread to my brain.I am 18 years old or older.I have been diagnosed with vulvar cancer.My cancer's origin is unknown.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- 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.
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