Lung CancerPhase 1NCT01998529
Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy
A Phase 1 study testing Cisplatin and Amifostine in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerated dose of heated cisplatin that can be given to patients with lung tumors. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Cisplatin and Amifostine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2014to 25 Aug 2020
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age >/= 3 years to </= 21 years.
- Histologically or genetically proven unilateral primary or metastatic active pleural malignancy.
- Radiologic workup must demonstrate that the thoracic disease is confined to only one hemi-thoracic cavity and must be deemed potentially resectable by the surgical team.
- The extrathoracic disease must be controlled.
- Patients must have a minimum expected duration of survival of 8 weeks as determined and documented by the attending surgeon or medical oncologist.
- Patients must not have any systemic illness which precludes them from being an operative candidate.
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- Patients must have Adequate Renal Function Defined as: Creatinine clearance or radioisotope GFR >/=70ml/min/1.73 m^2 or a serum creatinine based on age/gender less than listed value in the table below: 1 to < 2 years 0.6 mg/dL for both males and females, 2 to < 6 years 0.8 mg/dL for both males and females, 6 to < 10 years 1 mg/dL for both males and females, 10 to < 13 years 1.2 mg/dL for both males and females, 13 to < 16 years 1.5 mg/dL for males and 1.4 mg/dL for females, >/= 16 years 1.7 for males and 1.4 for females
- Patients will be eligible if the WBC is >/=1500/µl or ANC is >/=1,000 and platelets are >/= 50,000/mm^3
- Adequate Liver Function Defined as: -Bilirubin (sum of conjugated + unconjugated) </= 1.5 x upper limit of normal (ULN) for age -SGPT (ALT) </=110 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L. -Serum albumin >/= 2 g/dL.
- Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment
Who cannot join
- Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
- Patients who have failed previous hemi-thoracic platinum therapy will be ineligible ("Failed" is having disease recurrence </= 3 months).
- No pregnant or lactating females.
- Patients will be ineligible if they have a lymphoma diagnosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy
The goal of this clinical research study is to find the highest tolerated dose of heated cisplatin that can be given to patients with lung tumors. The safety of this drug will also be studied.
Read the detailed description
Surgery and Study Drug Administration:
If you are found to be eligible to take part in this study, chest surgery will be performed to try to remove as many tumors as possible. The chest surgery is not being performed specifically for this research study and would be performed as part of your standard of care treatment even if you didn't take part in this study. You will be given a separate consent form to sign that explains the details and risks of chest surgery in more detail.
During the chest surgery, you will receive amifostine by vein to help prevent possible side effects, such as ear and/or kidney damage. The chest will then be closed with a plastic tube left in place. Then, the chest wash will begin. During the chest wash, a pump that is connected to the plastic tube pushes the heated cisplatin into the chest and then pulls it out to recirculate the cisplatin. The surgeon will also wash over the closed area of the surgical site with heated cisplatin. The heated cisplatin will be recirculated in and out of the chest over 60 minutes while the surgeon gently presses on the chest wall to help the cisplatin reach all areas in the chest. The plastic tube the heated cisplatin will be pumped through will stay in place after the surgery to drain the extra fluid. These are the same plastic tubes that would be present even if you did not agree to take part in this study.
During the surgery, extra blood (about ½ teaspoon each time) and fluid from the chest area will be collected for pharmacokinetic (PK) testing when you begin to receive the first infusion of the heated cisplatin, then 30 and 60 minutes after the infusion has started, and again 24 hours after receiving the heated cisplatin. The blood and fluid from the chest area will be collected through already placed catheters, so no additional needle sticks will be required. PK testing measures the amount of study drug in the body at different time points.
There is a chance that the surgeon may decide during the surgery that the chest wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, your doctor will discuss other treatment options with you after the surgery is complete.
Study Visits:
On Days 1-5, 11, and 14, (Day 1 being the day after surgery):
- Blood (about 1 teaspoon) will be drawn for routine tests.
- You will have a physical exam.
Follow-Up Visits:
About 1 month after the surgery is complete, you will have a follow-up visit and the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 1-3 teaspoons) will be drawn for routine tests.
- You will have a hearing test at the 1 month visit only.
It is recommended that you have follow-up visits at MD Anderson at 3 and 6 months after surgery. In addition to blood draws (about 1-3 teaspoons), you will have an MRI, CT, or PET-CT scan to check the status of the disease. These 3 and 6 month visits after surgery may be performed at your local doctor's office and/or laboratory.
Length of Study:
You will remain on study for up to 6 months. You will be taken off study if the disease gets worse.
If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, you may be eligible to have the operation with heated cisplatin wash repeated. If you are eligible for to have the surgery repeated, your active participation on this study will end and then you will be given a new consent form to sign in order to be re-enrolled back onto this study.
This is an investigational study. Cisplatin is FDA-approved and commercially available for the treatment of advanced bladder cancer, metastatic testicular cancer, metastatic ovarian cancer, hepatoblastoma, neuroblastoma, metastatic appendiceal cancer, and abdominal mesothelioma. The use of a heated cisplatin wash during chest surgery in patients with lung tumors is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Lung Cancer
- Being tested
- Cisplatin, Amifostine
- Keywords
- Lung Cancer, Unilateral Pleural Malignancy, Metastatic active pleural malignancy, Lung tumors, Sarcomas, Cytoreductive Surgery, Hyperthermic Intrathoracic Pleural Chemotherapy, HITC, Cisplatin, Platinol-AQ, Platinol, CDDP, Amifostine, Ethyol, Ethiofos, Gammaphos
- Medical subject headings
- Lung Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol-AQ, Platinol, CDDP
Starting dose of hyperthermic cisplatin 120 mg/m2. Perfusion continued for 60 minutes after adding the cisplatin at a target temperature of 41 C (+0.5 C).
AmifostineDrug
Also called Ethyol, Ethiofos, Gammaphos
Amifostine administered intravenously over 15 minutes beginning 30 minutes (+ 15 minutes) after the cisplatin perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | Experimental | After cytoreductive surgery, possible pneumonectomy, and possible diaphragm resection, the chest cavity will be closed in layers, leaving inflow and outflow chest tubes in place. Catheters connected to an extracorporeal perfusion circuit. Starting dose of hyperthermic cisplatin 120 mg/m2. Perfusion continued for 60 minutes after adding the cisplatin at a target temperature of 41 C (+0.5 C). In order to limit the systemic toxicity of cisplatin, amifostine administered intravenously over 15 minutes beginning 30 minutes after cisplatin perfusion. Patient response to amifostine continuously monitored by anesthesiologist. Infusion may be stopped and/or restarted based on blood pressure. Receives: Drug: Cisplatin; Drug: Amifostine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Hyperthermic Intrathoracic Pleural Chemotherapy (HITC)
If 2 dose limiting toxicities (DLTs) are observed at a given dose level, MTD has been exceeded. Dose level below expanded to a total of 6 patients and if </= 1 out of 6 patients experience a DLT at this dose level, this will be defined as the MTD.
Dose limiting toxicity may occur at any time during the initial hospitalization before discharge following the HITC. The dose limiting toxicity is defined two ways. Hematologic DLT is defined as Grade IV neutropenia, anemia, or thrombocytopenia. Non-hematologic DLT is any Grade III or IV non-hematologic toxicity excluding Grade III nausea or vomiting, Grade III hepatic toxicity which returns to Grade I within four weeks of the HITC, or before hospital discharge, or Grade III fever occurring after the HITC.
Measured: Change in dose levels at 30 and 60 minutes after the infusion has started, and again 24 hours after receiving the heated cisplatin
Secondary outcomes (1)
Time to Relapse
Evaluation of measurable disease performed 3 months and 6 months postoperatively (+2 weeks) using CT and physical exam. Disease progression defined by radiographically visible nodules greater than 1.5 cm.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2013 (estimated)
- Study start20 Aug 2014
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rice, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998529
- Sponsor's protocol ID
- 2012-0657
- Other IDs
- NCI-2014-00510
- Status last verified
- Sep 2023
- First submitted
- 19 Nov 2013
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy
- ClinicalTrials.gov ID
- NCT01998529
- Acronym / sponsor ID
- 2012-0657
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Unilateral Pleural Malignancy, Metastatic active pleural malignancy, Lung tumors, Sarcomas, Cytoreductive Surgery, Hyperthermic Intrathoracic Pleural Chemotherapy, HITC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 20 Aug 2014 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 29 Nov 2013 (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.
The goal of this clinical research study is to find the highest tolerated dose of heated cisplatin that can be given to patients with lung tumors. The safety of this drug will also be studied.
Detailed description
Surgery and Study Drug Administration:
If you are found to be eligible to take part in this study, chest surgery will be performed to try to remove as many tumors as possible. The chest surgery is not being performed specifically for this research study and would be performed as part of your standard of care treatment even if you didn't take part in this study. You will be given a separate consent form to sign that explains the details and risks of chest surgery in more detail.
During the chest surgery, you will receive amifostine by vein to help prevent possible side effects, such as ear and/or kidney damage. The chest will then be closed with a plastic tube left in place. Then, the chest wash will begin. During the chest wash, a pump that is connected to the plastic tube pushes the heated cisplatin into the chest and then pulls it out to recirculate the cisplatin. The surgeon will also wash over the closed area of the surgical site with heated cisplatin. The heated cisplatin will be recirculated in and out of the chest over 60 minutes while the surgeon gently presses on the chest wall to help the cisplatin reach all areas in the chest. The plastic tube the heated cisplatin will be pumped through will stay in place after the surgery to drain the extra fluid. These are the same plastic tubes that would be present even if you did not agree to take part in this study.
During the surgery, extra blood (about ½ teaspoon each time) and fluid from the chest area will be collected for pharmacokinetic (PK) testing when you begin to receive the first infusion of the heated cisplatin, then 30 and 60 minutes after the infusion has started, and again 24 hours after receiving the heated cisplatin. The blood and fluid from the chest area will be collected through already placed catheters, so no additional needle sticks will be required. PK testing measures the amount of study drug in the body at different time points.
There is a chance that the surgeon may decide during the surgery that the chest wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, your doctor will discuss other treatment options with you after the surgery is complete.
Study Visits:
On Days 1-5, 11, and 14, (Day 1 being the day after surgery):
- Blood (about 1 teaspoon) will be drawn for routine tests.
- You will have a physical exam.
Follow-Up Visits:
About 1 month after the surgery is complete, you will have a follow-up visit and the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 1-3 teaspoons) will be drawn for routine tests.
- You will have a hearing test at the 1 month visit only.
It is recommended that you have follow-up visits at MD Anderson at 3 and 6 months after surgery. In addition to blood draws (about 1-3 teaspoons), you will have an MRI, CT, or PET-CT scan to check the status of the disease. These 3 and 6 month visits after surgery may be performed at your local doctor's office and/or laboratory.
Length of Study:
You will remain on study for up to 6 months. You will be taken off study if the disease gets worse.
If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, you may be eligible to have the operation with heated cisplatin wash repeated. If you are eligible for to have the surgery repeated, your active participation on this study will end and then you will be given a new consent form to sign in order to be re-enrolled back onto this study.
This is an investigational study. Cisplatin is FDA-approved and commercially available for the treatment of advanced bladder cancer, metastatic testicular cancer, metastatic ovarian cancer, hepatoblastoma, neuroblastoma, metastatic appendiceal cancer, and abdominal mesothelioma. The use of a heated cisplatin wash during chest surgery in patients with lung tumors is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | Experimental | Drug: Cisplatin, Drug: AmifostineAfter cytoreductive surgery, possible pneumonectomy, and possible diaphragm resection, the chest cavity will be closed in layers, leaving inflow and outflow chest tubes in place. Catheters connected to an extracorporeal perfusion circuit. Starting dose of hyperthermic cisplatin 120 mg/m2. Perfusion continued for 60 minutes after adding the cisplatin at a target temperature of 41 C (+0.5 C). In order to limit the systemic toxicity of cisplatin, amifostine administered intravenously over 15 minutes beginning 30 minutes after cisplatin perfusion. Patient response to amifostine continuously monitored by anesthesiologist. Infusion may be stopped and/or restarted based on blood pressure. |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Age >/= 3 years to </= 21 years.
- Histologically or genetically proven unilateral primary or metastatic active pleural malignancy.
- Radiologic workup must demonstrate that the thoracic disease is confined to only one hemi-thoracic cavity and must be deemed potentially resectable by the surgical team.
- The extrathoracic disease must be controlled.
- Patients must have a minimum expected duration of survival of 8 weeks as determined and documented by the attending surgeon or medical oncologist.
Key exclusion criteria (4 listed)
- Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
- Patients who have failed previous hemi-thoracic platinum therapy will be ineligible ("Failed" is having disease recurrence </= 3 months).
- No pregnant or lactating females.
- Patients will be ineligible if they have a lymphoma diagnosis.
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 |
|---|---|---|
| CisplatinAlso: Platinol-AQ, Platinol, CDDPStarting dose of hyperthermic cisplatin 120 mg/m2. Perfusion continued for 60 minutes after adding the cisplatin at a target temperature of 41 C (+0.5 C). | Drug | Cisplatin |
| AmifostineAlso: Ethyol, Ethiofos, GammaphosAmifostine administered intravenously over 15 minutes beginning 30 minutes (+ 15 minutes) after the cisplatin perfusion. | Drug | Cisplatin |
Primary outcome
Maximum Tolerated Dose (MTD) of Hyperthermic Intrathoracic Pleural Chemotherapy (HITC)
Time frame: Change in dose levels at 30 and 60 minutes after the infusion has started, and again 24 hours after receiving the heated cisplatin
If 2 dose limiting toxicities (DLTs) are observed at a given dose level, MTD has been exceeded. Dose level below expanded to a total of 6 patients and if </= 1 out of 6 patients experience a DLT at this dose level, this will be defined as the MTD. Dose limiting toxicity may occur at any time during the initial hospitalization before discharge following the HITC. The dose limiting toxicity is defined two ways. Hematologic DLT is defined as Grade IV neutropenia, anemia, or thrombocytopenia. Non-hematologic DLT is any Grade III or IV non-hematologic toxicity excluding Grade III nausea or vomiting, Grade III hepatic toxicity which returns to Grade I within four weeks of the HITC, or before hospital discharge, or Grade III fever occurring after the HITC.
1 secondary outcome
Time to Relapse
Time frame: 3 months
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 14 Sep 2023.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
David Rice, 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 Cisplatin and Amifostine in people with Lung Cancer, 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 4 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 14 Sep 2023. 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) of Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) (time frame: Change in dose levels at 30 and 60 minutes after the infusion has started, and again 24 hours after receiving the heated cisplatin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2023.