Advanced Cancers Clinical Trial
Official title:
A Phase I Trial of Ipilimumab (Anti CTLA- 4 Antibody) in Combination With Lenalidomide (IMiD) in Patients With Advanced Malignancies
The goal of this clinical research study is to find the highest tolerable dose of the
combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to
patients with advanced cancer. The safety of these drugs will also be studied.
Ipilimumab is designed to increase the immune system's ability to fight cancer.
Lenalidomide is designed to change the body's immune system. It may also interfere with the
development of tiny blood vessels that help support tumor growth. This may decrease the
growth of cancer cells.
Study Groups:
Dose escalation:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of the study drugs based on when you join the study.
Up to 5 dose levels of ipilimumab with lenalidomide will be tested. Up to 6 participants will
be enrolled at each dose level. The first group of participants will receive the lowest dose
level. Each new group will receive a higher dose than the group before it, if no intolerable
side effects were seen. This will continue until the highest tolerable dose of ipilimumab
with lenalidomide is found.
Dose expansion:
Once the highest tolerable dose of ipilimumab with lenalidomide is found, up to 14 more
participants may be enrolled. This will be to further study the safety of the combination of
drugs at that dose and the level of effectiveness of the study drugs in a certain tumor
group. This group will be called the dose expansion group.
Study Drug Administration:
Each study cycle is 28 days.
You will take lenalidomide by mouth on Days 1-21 of each cycle. You will swallow the capsules
whole with water once a day. Do not break, chew, or open your capsules. The doctor will
discuss this with you.
You will receive ipilimumab by vein over 90 minutes on Day 1 of each cycle. You will be
monitored for side effects for 1-2 hours after the infusion.
Study Visits:
Every study visit:
° You will be asked if you have had any side effects.
Cycle 1:
- On Day 1: blood (about 4 teaspoons) will be drawn for routine tests.
- Between Days 2 and 7: If you are able to become pregnant, you will have a blood (about 1
teaspoon) or urine pregnancy test.
- Between Days 8 and 14: Blood (about 4 teaspoons) will be drawn for routine tests. If you
are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy
test.
- Between Days 15 and 21: Blood (about 4 teaspoons) will be drawn for routine tests. If
you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
pregnancy test.
- Between Days 22 and 28: Blood (about 4 teaspoons) will be drawn for routine tests. Your
medical history will be recorded.
Cycle 2:
- On Day 1: Blood (about 4 teaspoons) will be drawn for routine tests.
- On Day 8 (+/- 3 days): Blood (about 4 teaspoons) will be drawn for routine tests.
- On Day 15 (+/- 3 days): Blood (about 4 teaspoons) will be drawn for routine tests.
- On Day 22 (+/- 3 days): Blood (about 4 teaspoons) will be drawn for routine tests.
Every other cycle (every 8 weeks):
° You will have an x-ray, CT scan, and/or PET/CT scan to check the status of the disease. °
Blood (about 1 tablespoon) will be drawn for tumor marker testing.
Before starting Cycle 3 and all following cycles:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- You will be asked about any health problems you may have and any other drugs or herbal
supplements you may be taking.
- Your performance status will be recorded.
- Blood (about 4 teaspoons) will be drawn for routine tests. Blood may be drawn more often
if your doctor thinks it is needed.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
pregnancy test.
At the End of the study:
- Directly at the end of the study: If you are able to become pregnant, you will have a
blood (about 1 teaspoon) or urine pregnancy test.
- 28 days after therapy with lenalidomide stopped: If you are able to become pregnant, you
will have a blood (about 1 teaspoon) or urine pregnancy test.
Length of Dosing:
You may receive up to 4 doses of ipilimumab. You may continue receiving lenalidomide for as
long as the doctor thinks it is in your best interest. 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.
You will be off study after your follow-up visit.
Follow-up:
You will have a follow-up-visit within 30 days after your last dose of study drugs. You will
be asked about any health problems you may have and if you have had any side effects. If your
study doctor thinks it is needed, you may have follow-up for a longer period of time. If you
are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy
test.
This is an investigational study. Ipilimumab is FDA approved and commercially available to
treat metastatic melanoma. Lenalidomide is FDA approved and commercially available to treat
multiple myeloma and myelodysplastic syndrome. Giving the combination of ipilimumab and
lenalidomide to patients with advanced cancer is investigational.
Up to 101 patients will be enrolled in this study. All will be enrolled at MD Anderson.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01213238 -
Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab
|
Phase 1 | |
Recruiting |
NCT02160366 -
Profile Related Evidence to Determine Individualized Cancer Therapy (PREDICT) Program in Advanced Cancer Patients
|
||
Completed |
NCT00903708 -
LY2275796 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00379353 -
The Effects of Thalidomide on Symptom Clusters
|
Phase 2 | |
Terminated |
NCT00499382 -
Quantitation of Left Ventricular Ejection Fraction as Part of F-18 FDG Whole Body PET/CT Scans For Tumor Staging
|
N/A | |
Completed |
NCT02459964 -
Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain
|
Phase 4 | |
Completed |
NCT01430572 -
Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients
|
Phase 1 | |
Completed |
NCT02561234 -
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01375114 -
The Effects of Ginseng on Cancer-Related Fatigue
|
Phase 2 | |
Completed |
NCT01454804 -
Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors
|
Phase 1 | |
Completed |
NCT01201694 -
Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L)
|
Phase 1 | |
Completed |
NCT02801045 -
Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient
|
N/A | |
Completed |
NCT02873975 -
A Study of LY2606368 (Prexasertib) in Patients With Solid Tumors With Replicative Stress or Homologous Repair Deficiency
|
Phase 2 | |
Completed |
NCT01983969 -
Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT02272595 -
Rational Therapeutics Based on Matched Tumor and Normal Tissue
|
||
Active, not recruiting |
NCT01999491 -
A Phase 1 Dose-Escalation and Pharmacokinetic Study of NC-4016 in Patients With Advanced Solid Tumors or Lymphoma
|
Phase 1 | |
Recruiting |
NCT03375983 -
Plasmodium Immunotherapy for Advanced Cancers
|
Phase 1/Phase 2 | |
Completed |
NCT02571036 -
A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies
|
Phase 1 | |
Withdrawn |
NCT01608139 -
Study of Curcumin, Vorinostat, and Sorafenib
|
Phase 1 | |
Completed |
NCT01024166 -
Patient-Reported Outcomes-Based Palliative and Hospice Care Practice: A Usability Study
|
N/A |