Solid TumorsPhase 1NCT00509782
Phase I Trial of ZIO-101 in Patients With Solid Tumors
A Phase 1 study testing ZIO-101 in people with Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors. 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ZIO-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Apr 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histological confirmation solid malignancy refractory to conventional standard therapies for their condition.
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents.
- Pediatric patients will be eligible at the discretion of the primary investigator.
- ECOG performance status score </= 2.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods.
- Patients must provide written informed consent prior to treatment.
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- At least four weeks from completion of prior therapy to day 1 of study drug.
- Baseline toxicity assessment less than or equal to grade 1 except treatment induced alopecia (NCI Common Terminology Criteria for Adverse Events [CTCAE] version 3.0).
- Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values: - Serum creatinine </= 2 times the upper normal limit OR a calculated creatinine clearance </= 50 cc/min. - Total bilirubin </= 2 times the upper normal limit. - Alanine aminotransferase (ALT), OR aspartate aminotransferase (AST) </= 3 times the upper limit of normal.
- Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 cells/microL.
Who cannot join
- Uncontrolled systemic infection (documented with microbiological studies).
- Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Patient has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Patient experiences symptoms even while at rest.
- Concomitant therapy for solid cancer.
- Pregnant subjects and those who are breast-feeding.
- History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I Endometrial/Cervical Carcinoma or Prostate Carcinoma treated surgically, and non-melanoma skin cancer.
- Documented personal or family history of prolonged QT syndrome.
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- 12 lead electrocardiogram with a corrected QT interval >/= 460 milliseconds.
- History of confusion or dementia.
- History of seizure disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Primary Objectives:
- To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors.
- To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks.
Secondary Objective:
- To determine the anti-tumor effects of ZIO-101.
Read the detailed description
ZIO-101 is a drug that may change cancerous cells into healthy (benign) cells. It is also designed to cause cancer cells to destroy themselves; a term called apoptosis.
Before you can start treatment on this study, you will have what are called "screening tests" no more than one week before starting the study. These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including measurements of your weight, blood pressure, pulse, and temperature. You will also be asked what other medicines you are taking and about your general well-being. You will have an electrocardiogram (ECG - a test to measure the electrical activity of the heart). Blood (about 2 1/2 tablespoons) will be drawn. A sample of urine will be also be collected and tested to see if your kidneys are working correctly. Women who are able to have children must have a negative urine pregnancy test.
To see the current condition of your tumor, additional tests may need to be performed if they have not already been done recently. These tests may include a chest x-ray, a CT scan (imaging computer pictures of your body), a bone scan (an imaging test of your bones with a contrast material), or an MRI (a detailed imaging scan of certain areas of your body).
If you are found to be eligible to take part in this study, you will begin treatment with ZIO-101. Immediately before being treated with ZIO-101 on Day 0, you will have another physical exam and you will be asked about any medicines you are taking and how you are feeling. You will also be asked a series of questions which will assess your mental health. This is called a mini-mental status exam and will take approximately 10 minutes to complete. The blood tests may need to be repeated along with the ECG and the urine test. In addition, a small blood sample (about 10 teaspoons) must be taken immediately before the injection of ZIO-101. This blood will be used to help in the measurement of drug levels in the blood. These are called pharmacokinetic (PK) tests. This blood sample will also be used to measure arsenic levels in your blood.
ZIO-101 will be injected into your vein over 60 minutes in the clinical translational research center of UTMDACC. This drug must be given through a special IV called a central line catheter so that it does not damage your surrounding tissue. You will have to sign a separate consent document before placement of a catheter can be performed. Special care will be taken to be sure the drug does not leak into surrounding tissue. The use of anti-nausea and other supportive care medications may be given during the infusion.
Following the injection, you will have 6 samples of blood taken for PK tests at half an hour and 1, 2, 4, 8, and 12 hours after finishing the treatment.
For the next 4 days at about the same time as your first infusion, you will be prepared for treatment with ZIO-101. Before each injection, you will be asked how you feel, an ECG will be performed, and a small sample of blood (about 2 teaspoons) will be drawn for PK tests. The Day 1-4 infusions will also each take about 1 hour. In total you will receive 5 daily injections of ZIO-101. On Day 4 at the end of the infusion, another sample of blood will be drawn (about 5 teaspoons) to measure arsenic levels in your blood.
Your next visit will be Week 2 and at the start of this visit, a blood sample (about 2 teaspoons) will be drawn for PK tests, and you will be asked how you feel. At Week 3, another blood sample (about 7 teaspoons) will be drawn for PK tests, and to measure arsenic levels in your blood, and you will again be asked how you feel.
At Week 4, a new cycle begins. Immediately before being treated with ZIO-101, you will have a physical examination and you will take a mini-mental status examination; you will be asked about any medicines you are taking and how you are feeling. The blood tests will be repeated along with the ECG and the routine urine test. In addition, tests to measure your tumor will be repeated.
This study is trying to find the best dose of ZIO-101. At first, 3 patients will be assigned to the first dose level. They will be followed to evaluate their side effects for a period of 4 weeks before 3 more patients are enrolled. If none of the patients develop serious side effects, the dose escalation will continue. If 1 of the 3 patients in a particular dose level develops significant side effects, 3 more patients will be enrolled at that level. If 2 or more of the 6 patients develop serious side effects, then the escalation will finish and all future patients on this study will be treated at a lower dose level (half way between this level and the previous one).
You may receive up to 6 cycles of treatment. You may be taken off study early if your disease gets worse or intolerable side effects occur. Once you go off study, you will have an end of study visit. During this visit, you will have a physical exam, a mini-mental status exam and blood (about 3 teaspoons) will be drawn for routine tests.
This is an investigational study. ZIO-101 has been authorized by the FDA for use in research only. ZIO-101 will be provided free of charge during the study. Also, any tests or procedures that are being done solely for the purpose of this research study will be provided free of charge. Up to 50 patients will take part in this multicenter study. All will be enrolled at M. D. Anderson.
- Conditions
- Solid Tumors
- Being tested
- ZIO-101
- Keywords
- Solid Tumors, Anti-Tumor Effects, ZIO-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIO-101Drug
Starting Dose 78 mg/m^2 intravenously daily for 5 consecutive days repeated every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ZIO-101 | Experimental | Not described Receives: Drug: ZIO-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: Daily for 5 consecutive days repeated every 4 weeks for 1 cycle; evaluation of 4-6 dose escalations to determine an MTD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startMay 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alaunos Therapeutics
- Responsible party
- Sponsor
- Investigators
- Razelle Kurzrock, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509782
- Sponsor's protocol ID
- 2004-0909
- Status last verified
- Jul 2012
- First submitted
- 30 Jul 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsimberidou AM, Camacho LH, Verstovsek S, Ng C, Hong DS, Uehara CK, Gutierrez C, Daring S, Stevens J, Komarnitsky PB, Schwartz B, Kurzrock R. A phase I clinical trial of darinaparsin in patients with refractory solid tumors. Clin Cancer Res. 2009 Jul 15;15(14):4769-76. doi: 10.1158/1078-0432.CCR-08-2984. Epub 2009 Jul 7.
PubMed 19584162
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of ZIO-101 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00509782
- Acronym / sponsor ID
- 2004-0909
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors, Anti-Tumor Effects, ZIO-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Alaunos Therapeutics
- Study start
- May 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Jul 2007 (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.
Primary Objectives:
- To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors.
- To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks.
Secondary Objective:
- To determine the anti-tumor effects of ZIO-101.
Detailed description
ZIO-101 is a drug that may change cancerous cells into healthy (benign) cells. It is also designed to cause cancer cells to destroy themselves; a term called apoptosis.
Before you can start treatment on this study, you will have what are called "screening tests" no more than one week before starting the study. These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including measurements of your weight, blood pressure, pulse, and temperature. You will also be asked what other medicines you are taking and about your general well-being. You will have an electrocardiogram (ECG - a test to measure the electrical activity of the heart). Blood (about 2 1/2 tablespoons) will be drawn. A sample of urine will be also be collected and tested to see if your kidneys are working correctly. Women who are able to have children must have a negative urine pregnancy test.
To see the current condition of your tumor, additional tests may need to be performed if they have not already been done recently. These tests may include a chest x-ray, a CT scan (imaging computer pictures of your body), a bone scan (an imaging test of your bones with a contrast material), or an MRI (a detailed imaging scan of certain areas of your body).
If you are found to be eligible to take part in this study, you will begin treatment with ZIO-101. Immediately before being treated with ZIO-101 on Day 0, you will have another physical exam and you will be asked about any medicines you are taking and how you are feeling. You will also be asked a series of questions which will assess your mental health. This is called a mini-mental status exam and will take approximately 10 minutes to complete. The blood tests may need to be repeated along with the ECG and the urine test. In addition, a small blood sample (about 10 teaspoons) must be taken immediately before the injection of ZIO-101. This blood will be used to help in the measurement of drug levels in the blood. These are called pharmacokinetic (PK) tests. This blood sample will also be used to measure arsenic levels in your blood.
ZIO-101 will be injected into your vein over 60 minutes in the clinical translational research center of UTMDACC. This drug must be given through a special IV called a central line catheter so that it does not damage your surrounding tissue. You will have to sign a separate consent document before placement of a catheter can be performed. Special care will be taken to be sure the drug does not leak into surrounding tissue. The use of anti-nausea and other supportive care medications may be given during the infusion.
Following the injection, you will have 6 samples of blood taken for PK tests at half an hour and 1, 2, 4, 8, and 12 hours after finishing the treatment.
For the next 4 days at about the same time as your first infusion, you will be prepared for treatment with ZIO-101. Before each injection, you will be asked how you feel, an ECG will be performed, and a small sample of blood (about 2 teaspoons) will be drawn for PK tests. The Day 1-4 infusions will also each take about 1 hour. In total you will receive 5 daily injections of ZIO-101. On Day 4 at the end of the infusion, another sample of blood will be drawn (about 5 teaspoons) to measure arsenic levels in your blood.
Your next visit will be Week 2 and at the start of this visit, a blood sample (about 2 teaspoons) will be drawn for PK tests, and you will be asked how you feel. At Week 3, another blood sample (about 7 teaspoons) will be drawn for PK tests, and to measure arsenic levels in your blood, and you will again be asked how you feel.
At Week 4, a new cycle begins. Immediately before being treated with ZIO-101, you will have a physical examination and you will take a mini-mental status examination; you will be asked about any medicines you are taking and how you are feeling. The blood tests will be repeated along with the ECG and the routine urine test. In addition, tests to measure your tumor will be repeated.
This study is trying to find the best dose of ZIO-101. At first, 3 patients will be assigned to the first dose level. They will be followed to evaluate their side effects for a period of 4 weeks before 3 more patients are enrolled. If none of the patients develop serious side effects, the dose escalation will continue. If 1 of the 3 patients in a particular dose level develops significant side effects, 3 more patients will be enrolled at that level. If 2 or more of the 6 patients develop serious side effects, then the escalation will finish and all future patients on this study will be treated at a lower dose level (half way between this level and the previous one).
You may receive up to 6 cycles of treatment. You may be taken off study early if your disease gets worse or intolerable side effects occur. Once you go off study, you will have an end of study visit. During this visit, you will have a physical exam, a mini-mental status exam and blood (about 3 teaspoons) will be drawn for routine tests.
This is an investigational study. ZIO-101 has been authorized by the FDA for use in research only. ZIO-101 will be provided free of charge during the study. Also, any tests or procedures that are being done solely for the purpose of this research study will be provided free of charge. Up to 50 patients will take part in this multicenter study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZIO-101 | Experimental | Drug: ZIO-101 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histological confirmation solid malignancy refractory to conventional standard therapies for their condition.
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents.
- Pediatric patients will be eligible at the discretion of the primary investigator.
- ECOG performance status score </= 2.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods.
Key exclusion criteria (9 listed)
- Uncontrolled systemic infection (documented with microbiological studies).
- Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Patient has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Patient experiences symptoms even while at rest.
- Concomitant therapy for solid cancer.
- Pregnant subjects and those who are breast-feeding.
- History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I Endometrial/Cervical Carcinoma or Prostate Carcinoma treated surgically, and non-melanoma skin cancer.
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 |
|---|---|---|
| ZIO-101Starting Dose 78 mg/m^2 intravenously daily for 5 consecutive days repeated every 4 weeks. | Drug | ZIO-101 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Daily for 5 consecutive days repeated every 4 weeks for 1 cycle; evaluation of 4-6 dose escalations to determine an MTD
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 1 Aug 2012.
- Results publication: PubMed 19584162Tsimberidou AM, Camacho LH, Verstovsek S, Ng C, Hong DS, Uehara CK, Gutierrez C, Daring S, Stevens J, Komarnitsky PB, Schwartz B, Kurzrock R. A phase I clinical trial of darinaparsin in patients with refractory solid tumors. Clin Cancer Res. 2009 Jul 15;15(14):4769-76. doi: 10.1158/1078-0432.CCR-08-2984. Epub 2009 Jul 7.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Solid Tumors
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Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Razelle Kurzrock, 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 ZIO-101 in people with Solid Tumors, 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 10 inclusion and 9 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 1 Aug 2012. 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) (time frame: Daily for 5 consecutive days repeated every 4 weeks for 1 cycle; evaluation of 4-6 dose escalations to determine an MTD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00509782, which also lists 1 linked publication.
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 1 Aug 2012.