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IT-101 Clinical Trial





UPDATE:
The IT-101 clinical trial at City of Hope is currently enrolling a limited number of additional participants. At this time, there is a waiting list of people who are eligible to become part of the clinical trial. Patients added to the list will be enrolled as space becomes available. If you are interested in enrolling in the IT-101 clinical trial, you will need to be evaluated in person by our doctors, who can then determine your eligibility for IT-101 or any other clinical trial being conducted at City of Hope.

In order to potentially participate in any clinical trial at City of Hope, including IT-101, you must first register as a patient with New Patient Services and be evaluated by our doctors. Evaluations cannot be conducted over the phone or by email


To become a patient at
City of Hope, please
click here or call New Patient Services at 866-434-4673.

To search open clinical trials at City of Hope:  http://clinicaltrials.coh.org.

To search open clinical trials across the U.S - http://www.clinicaltrials.gov.

IT-101 Clinical Trial



The Public TV program "Curious" profiled a patient who was being treated with an experimental drug in a clinical trial at City of Hope. You can find out more information about the trial here. You will also find links to Web sites that allow you to search for all open clinical trials being conducted at City of Hope and across the U.S.

If you need any additional information about the IT-101 clinical trial conducted at City of Hope after reading the Q&A, you can send us an email, and we will respond as soon as we can. Thank you.


What is IT-101?
IT-101 is an experimental drug, developed by Insert Therapeutics, that acts as a targeted chemotherapy. The drug uses the cancer-killing compound camptothecin, which is engineered into a nanoparticle to attack cancer cells but leave healthy tissue alone.

Researchers are investigating how effective the drug is against tumors and if it can lessen the severity of side effects common to chemotherapy such as nausea, vomiting, hair loss and fatigue. You can find more detailed information about the compound itself on the Insert Therapeutics Web site (http://www.insertt.com/).

Where can I get IT-101?  When will it be available?
IT-101 is an experimental drug currently in an early stage, Phase I. Only patients enrolled in the clinical trial can receive treatment with IT-101.

The IT-101 clinical trial at City of Hope is currently enrolling a limited number of additional participants. At this time, there is a waiting list of people who are eligible to become part of the clinical trial. Patients added to the list will be enrolled as space becomes available. If you are interested in enrolling in the IT-101 clinical trial, you will need to be evaluated in person by our doctors, who can then determine your eligibility for IT-101 or any other clinical trial being conducted at City of Hope.

In order to potentially participate in any clinical trial at City of Hope, including IT-101, you must first register as a patient with New Patient Services and be evaluated by our doctors. Evaluations cannot be conducted over the phone or by email. To become a patient, please click here or call New Patient Services at 866-434-4673.

All potential new drugs must undergo three phases of clinical trials and be reviewed by the U.S. Food and Drug Administration before they can be approved for general use. Each phase of testing can potentially take years to complete.

How do I enroll in the IT-101 clinical trial?
The IT-101 clinical trial at City of Hope is currently enrolling a limited number of additional participants. At this time, there is a waiting list of people who are eligible to become part of the clinical trial. Patients added to the list will be enrolled as space becomes available. If you are interested in enrolling in the IT-101 clinical trial, you will need to be evaluated in person by our doctors, who can then determine your eligibility for IT-101 or any other clinical trial being conducted at City of Hope.

In order to potentially participate in any clinical trial at City of Hope, including IT-101, you must first register as a patient with New Patient Services and be evaluated by our doctors. Evaluations cannot be conducted over the phone or by email. Please click here or call 866-434-4673 to contact New Patient Services.

Additional information can be found on the City of Hope Clinical Trials web site.

If I do not qualify for the IT-101 trial, can I still become a patient at City of Hope?
Yes.  You can request a referral from your doctor, or you can contact City of Hope's New Patient Services online or call (866) 434-4673 to initiate the process. 

Is the IT-101 trial being offered at other sites?
City of Hope is currently the only investigational site for the Phase I trial of IT-101. Insert Therapeutics will be conducting Phase II trials in 2008 at numerous sites. When available, these trials will be listed at various web sites including the US clinical trial site and at the Insert Therapeutics website.

You can visit the City of Hope Clinical Trials Web site (http://clinicaltrials.coh.org/) to search for other open clinical trials for which you may be eligible.  You can also visit ClinicalTrials.gov (http://www.clinicaltrials.gov/) to search for other cancer clinical trials being conducted throughout the U.S.

How is IT-101 different from regular chemotherapy?
Chemotherapy drugs interrupt the process of cell division and replication, which cancer cells do in an uncontrolled manner. Unfortunately, healthy cells also regularly carry out the same process of duplication, and standard chemotherapy kills both healthy and cancerous cells without distinction.

IT-101 uses the cancer-killing compound camptothecin, which is engineered into nanoparticles to attack cancer cells but leave healthy tissue alone. With less damage to healthy cells, the compound has the potential to lessen the severity of side effects common to chemotherapy such as nausea, vomiting, hair loss and fatigue.

Is the IT-101 trial only for a specific cancer?
City of Hope is currently conducting a Phase I trial that is testing dosage and safety with IT-101 against advanced solid tumors in patients with all cancers, including ovarian cancer, non-small cell lung cancer and pancreatic cancer. Phase II trials are planned in the future to study IT-101.

Will insurance cover my treatment on the clinical trial? 
Your insurance company has to approve the course of treatment to ensure reimbursement.

Find out more about Becoming a Patient at City of Hope.
Find out more about the IT-101 trial by emailing City of Hope
.
Find out more about City of Hope’s clinical trials
 - http://clinicaltrials.coh.org/.
Find out more about other clinical trials across the U.S - http://www.clinicaltrials.gov.

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