Advanced Cancers Clinical Trial
Official title:
Phase I Study of Surface-Controlled Water Soluble Curcumin (THERACURMIN CR-011L) in Patients With Advanced Malignancies
The goal of this clinical research study is to find the highest tolerable doses of surface-controlled water dispersible curcumin (curcumin) that can be given to patients with advanced cancer. The safety of this drug will also be studied.
The Study Drugs:
Curcumin is the active ingredient in the spice, turmeric. It is a natural anti-inflammatory
compound and has shown anti-tumor activity. Surface-controlled water dispersible curcumin is
designed to be better absorbed by the body than regular curcumin.
Study Groups:
The first group of participants will receive the lowest dose level. Each new group will
usually receive a higher dose than the group before it, if no intolerable side effects were
seen. Each group will have 3-6 participants. This will continue until the highest tolerable
dose of curcumin is found. Up to 6 dose levels of curcumin will be tested. Once the highest
tolerable dose of each arm is found, up to 14 extra participants will be enrolled for extra
safety testing.
In some cases, extra participants may be enrolled at dose levels shown to be safe for extra
safety and/or pharmacokinetic (PK) and pharmacodynamic (PD) testing.
You will be assigned to a dose level based on when you join this study.
The dose of the study drug that you receive may be lowered if you have any intolerable side
effects. If you are tolerating the treatment, your study drug dose may be increased after
the first cycle to the highest dose level shown to be safe.
Study Drug Administration:
Each study "cycle" is 28 days long.
You will take 1 dose of curcumin on Day 1 of Cycle 1. Starting on Day 2 of Cycle 1, you will
begin taking curcumin 2 times each day.
Curcumin is a liquid that comes in a bottle, and you will take it by mouth on an empty
stomach with a full glass of water (8 ounces). If you are not tolerating the doses and your
doctor thinks it is needed, you may take curcumin in divided doses several times a day with
food.
Study Visits:
Before your first dose of study drug and during Week 2 of Cycle 2, you will complete a
questionnaire about your quality of life. It should take about 5-10 minutes to complete.
Every week of Cycle 1 and then as often as the doctor thinks it is needed, blood (about 2
teaspoons) will be drawn for routine tests.
Before you begin each cycle:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will be asked about any side effects you may be having.
At the end of Cycle 2 and then every 2-3 cycles:
- You will have a chest x-ray, CT, MRI, and/or PET scan to check the status of the
disease. If the study doctor thinks it is needed, these scan may be performed more
often. You also may have extra types of scans not listed in this consent form.
- If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure
tumor markers.
PK Testing:
Blood (about ½ teaspoon each time) will be drawn for PK testing at the following times:
- On Day 1 of Cycle 1, blood will be drawn before the dose and then 6 more times over the
next 6 hours after the dose.
- On Day 2 of Cycle 1, blood will be drawn 1 time.
Length of Study:
You may remain on study for as long as the study doctor thinks it is in your best interest.
You will be taken off study early if the disease gets worse or you experience intolerable
side effects.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
Within 30 days after your last dose of the study drug(s), you will have an end-of-study
visit. At this visit the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked about any side effects you may be having.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT, MRI, and/or
PET scan to check the status of the disease. If the study doctor thinks it is needed,
you may also have extra types of scans.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to
measure tumor markers.
This is an investigational study. Curcumin is a commercially available substance, which is
commonly used as a food additive. Curcumin is not FDA approved for any usage. At this time,
curcumin is only being used in research.
Up to 72 patients will take part in this study. All will be enrolled at MD Anderson.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
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 | |
Terminated |
NCT02521194 -
Occupational Therapy in Palliative Care
|
N/A |