GlioblastomaPhase 1NCT00132158
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors
A Phase 1 study testing Irinotecan (Camptosar), Gefitinib (Iressa) in people with Glioblastoma and Rhabdomyosarcomas, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Glioblastoma, Rhabdomyosarcomas, Neuroblastoma
- What is being tested?
- Irinotecan (Camptosar), Gefitinib (Iressa)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Oct 2011
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient's age is less than or equal to 21 years at the time of study entry.
- Patient has a histologically or pathologically confirmed diagnosis of a recurrent solid tumor that did not respond to standard treatment or one for which there is no known therapy.
- Patient has adequate performance status, along with adequate function of the liver, kidney and bone marrow.
- Must have recovered from chemotherapy
- No active GVHD nor treatment for GVHD
Who cannot join
- Patient is receiving other cytotoxic or investigational drug or has evidence of another active illness
- Active diarrhea
- Active intercurrent serious or uncontrolled illness
- Pregnant or lactating
- Concomitant use of medications that may interact with study drugs
- Active infection
- Known history of life-threatening allergy or hypersensitivity to camptothecin Active interstitial lung disease
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: A Dose Finding Study (Phase I) of the Combination of ZD1839 (Iressa®) and an Oral Formulation of Irinotecan (Camptosar™) in Children With Refractory Solid Tumors
The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. In this study the intravenous (given into the vein) formula of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12. Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.
Read the detailed description
This is a phase I study to estimate the maximum tolerated dose and the dose limiting toxicities of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefitinib. This trial will use the EWOC method, which is an adaptive dose escalation scheme. The method is fully adaptive and makes use of all the information available at the time of each dose assignment, and directly addresses the ethical need to control the probability of overdosing. It is designed to approach the maximum tolerated dose (MTD) as fast as possible.
In this study the intravenous formulation of irinotecan will be given orally on days 1-5 and days 8-12 (dose level begins at 5 mg/m2 ). One patient will be treated at each dose level of irinotecan until moderate toxicity is observed. At the level where moderate toxicity is observed, the cohort size will be increased to 2 patients. Dosages will then be increased until the development of DLT as guided by the EWOC model. The estimated MTD will be continually reassessed using all data from preceding patients. The toxicity data of all patients enrolled in the trial are used to update the dose-toxicity relationship and to guide the next escalation/de-escalation. The calculation will be carried out with EWOC software. Patients will be enrolled and the dose assigned is determined based on previous participants' toxicity. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12 - [150 mg/m2 (maximum 250 mg)] Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.
Secondary Objectives Include:
- To describe dose-limiting toxicities (DLTs) of the combination of oral irinotecan and ZD1839 and to define their duration and reversibility.
- To investigate the pharmacokinetics of oral irinotecan and ZD1839 when given in combination in children with recurrent malignant solid tumors.
- To describe the relationship between pharmacokinetic parameters and toxicity.
- To describe any antitumor effects within the confines of a phase I study.
- To examine tumor expression of ErbB1 and/or ABCG2 with respect to pharmacokinetics and response.
- To examine the pharmacogenetic determinants of ZD1839 and irinotecan pharmacokinetics and pharmacodynamics.
- Conditions
- Glioblastoma, Rhabdomyosarcomas, Neuroblastoma, Osteosarcoma
- Being tested
- Irinotecan (Camptosar), Gefitinib (Iressa)
- Medical subject headings
- Glioblastoma, Rhabdomyosarcoma, Neuroblastoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan (Camptosar), Gefitinib (Iressa)Drug
See Detailed Description for treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Irinotecan (Camptosar), Gefitinib (Iressa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the maximum tolerated dose (MTD) of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefitinib.
Measured: Within the first 30 days of completion of first cycle of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Lisa M McGregor, MD, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132158
- Sponsor's protocol ID
- POCPZD
- Other IDs
- IRUSIRES0181
- Status last verified
- Apr 2012
- First submitted
- 17 Aug 2005
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding Study (Phase I) of the Combination of ZD1839 (Iressa®) and an Oral Formulation of Irinotecan (Camptosar™) in Children With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00132158
- Acronym / sponsor ID
- POCPZD
- Conditions
- Glioblastoma, Rhabdomyosarcomas, Neuroblastoma, Osteosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2005
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Aug 2005 (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 purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. In this study the intravenous (given into the vein) formula of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12. Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.
Detailed description
This is a phase I study to estimate the maximum tolerated dose and the dose limiting toxicities of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefitinib. This trial will use the EWOC method, which is an adaptive dose escalation scheme. The method is fully adaptive and makes use of all the information available at the time of each dose assignment, and directly addresses the ethical need to control the probability of overdosing. It is designed to approach the maximum tolerated dose (MTD) as fast as possible.
In this study the intravenous formulation of irinotecan will be given orally on days 1-5 and days 8-12 (dose level begins at 5 mg/m2 ). One patient will be treated at each dose level of irinotecan until moderate toxicity is observed. At the level where moderate toxicity is observed, the cohort size will be increased to 2 patients. Dosages will then be increased until the development of DLT as guided by the EWOC model. The estimated MTD will be continually reassessed using all data from preceding patients. The toxicity data of all patients enrolled in the trial are used to update the dose-toxicity relationship and to guide the next escalation/de-escalation. The calculation will be carried out with EWOC software. Patients will be enrolled and the dose assigned is determined based on previous participants' toxicity. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12 - [150 mg/m2 (maximum 250 mg)] Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.
Secondary Objectives Include:
- To describe dose-limiting toxicities (DLTs) of the combination of oral irinotecan and ZD1839 and to define their duration and reversibility.
- To investigate the pharmacokinetics of oral irinotecan and ZD1839 when given in combination in children with recurrent malignant solid tumors.
- To describe the relationship between pharmacokinetic parameters and toxicity.
- To describe any antitumor effects within the confines of a phase I study.
- To examine tumor expression of ErbB1 and/or ABCG2 with respect to pharmacokinetics and response.
- To examine the pharmacogenetic determinants of ZD1839 and irinotecan pharmacokinetics and pharmacodynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Irinotecan (Camptosar), Gefitinib (Iressa) |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patient's age is less than or equal to 21 years at the time of study entry.
- Patient has a histologically or pathologically confirmed diagnosis of a recurrent solid tumor that did not respond to standard treatment or one for which there is no known therapy.
- Patient has adequate performance status, along with adequate function of the liver, kidney and bone marrow.
- Must have recovered from chemotherapy
- No active GVHD nor treatment for GVHD
Key exclusion criteria (7 listed)
- Patient is receiving other cytotoxic or investigational drug or has evidence of another active illness
- Active diarrhea
- Active intercurrent serious or uncontrolled illness
- Pregnant or lactating
- Concomitant use of medications that may interact with study drugs
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 |
|---|---|---|
| Irinotecan (Camptosar), Gefitinib (Iressa)See Detailed Description for treatment plan. | Drug | 1 |
Primary outcome
To estimate the maximum tolerated dose (MTD) of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefitinib.
Time frame: Within the first 30 days of completion of first cycle of chemotherapy.
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 17 Apr 2012.
- St. Jude Children's Research HospitalLink 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.
Lisa M McGregor, MD, PhD principal investigator
St. Jude Children's Research Hospital
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 Irinotecan (Camptosar), Gefitinib (Iressa) in people with Glioblastoma and Rhabdomyosarcomas, run by St. Jude Children's Research Hospital 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 5 inclusion and 7 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 17 Apr 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?
To estimate the maximum tolerated dose (MTD) of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefitinib. (time frame: Within the first 30 days of completion of first cycle of chemotherapy.). 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 17 Apr 2012.