AstrocytomaPhase 2NCT00360828
Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas
A Phase 2 study testing Irinotecan Hydrochloride (HCI) Treatment and Continued Irinotecan Hydrochloride (HCI) Treatment in people with Astrocytoma and Glioma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma, Glioma, Oligodendroglioma
- What is being tested?
- Irinotecan Hydrochloride (HCI) Treatment and Continued Irinotecan Hydrochloride (HCI) Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Oct 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histological or neuroradiographic documented recurrent glioma defined as an anaplastic astrocytoma, mixed malignant glioma or oligodendroglioma. All patients must have had prior pathologic confirmation of primary tumor histology.
- Patients must be > than or equal to 18 years old.
- Patients must have a Karnofsky performance score (KPS) of > or equal to 50
- Measurable disease per MacDonald criteria is required
- Patients must have a predicted life expectancy of at least 12 weeks
- Required initial laboratory data:
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- Absolute Neutrophil Count (ANC) > 1,500
- Platelets > 100,000
- Serum Creatinine < 2.0
- Serum Bilirubin < 2.0
- Aspartamine transaminase/ Alanine transaminase (AST/ALT) < 3x normal
- Pregnancy test for females with child-bearing potential negative
- Patients must sign and date an IRB approved informed consent form stating he or she is aware of the neoplastic nature of the disease. Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. (Human protection committee approval of this protocol and consent form is required).
- Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up.
- Patients must have been previously treated with both surgery and radiotherapy.
- Prior adjuvant and one salvage chemotherapy regimen is permitted.
- Prior stereotactic radiotherapy is permitted.
Who cannot join
- Patients have evidence of leptomeningeal spread of disease.
- Patients having been treated with 2 or more salvage regimens.
- Pregnant or breast-feeding women. With the exception of post-menopausal or infertile women, a negative blood test for pregnancy is mandatory before entry on study. Fertile persons refusing to use adequate contraceptives may not participate.
- Patients with a history of irritable bowel disease, irritable bowel syndrome, chronic diarrhea or presence of a bowel obstruction.
- Patients with a second active malignancy or diagnosis of other cancer within 3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.
- Mentally incapacitated patients or psychiatric illness that would prevent the patient from giving informed consent.
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- Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.
- Known to be human immunodeficiency virus (HIV) positive or to have an acquired immunodeficiency syndrome (AIDS) related illness.
- Patients with an active infection that is not adequately controlled with antibiotics.
- Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Patients with a known sensitivity to any of the products to be administered during treatment.
- Patients currently enrolled in another clinical trial or patients who have participated in a trial of an investigational device or drug within the last 30 days.
- Patients previously treated with CPT-11.
- Concurrent stereotactic radiotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase II Study of Irinotecan HCI in Patients With Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas
Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine.
At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.
Read the detailed description
Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11) in patients with recurrent anaplastic astrocytomas (AA), mixed malignant glioma, and oligodendrogliomas (OA). Patients were to be stratified by tumor histology and treated with CPT-11 every 21 days (treatment cycle).
Baseline data (collected <14 days) was to consist of a neurological/oncological history, neurological examination, height, weight, performance status, Quality Of Life FACT-L questionnaire, laboratory studies to include complete blood count (CBC), differential, platelets, prothrombin time (PT), complete metabolic panel (CMP), Lactose dehydrogenase (LDH), and a pregnancy test, as well as a cranial Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) with and without contrast (to measure or evaluate the size and location of the tumor before treatment).
Administered every 21 days was a dose of irinotecan (CPT-11), zofran/Kytril/Anzemet, decadron, and intravenous (IV) atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.
Between days 15-21 (within 7 days of next scheduled CPT-11 treatment) the following tests were to be repeated - a neurological/oncological history and neurological examination, weight, blood drawn (CMP, LDH), performance status, and Quality Of Life FACT-L questionnaire. Also, a MRI (Cranial CT/MRI with and without contrast) was to be performed for tumor assessments at week 9, 18, 27, 36, and after every nine weeks thereafter until progression. Response was to be measured by a reduction in tumor size.
These supportive therapies were provided as necessary:
- Antiemetic Therapy
- Anticholinergics
- Loperamide (Imodium®)
- Growth Factors
- Other Concomitant Medications
- Conditions
- Astrocytoma, Glioma, Oligodendroglioma
- Being tested
- Irinotecan Hydrochloride (HCI) Treatment, Continued Irinotecan Hydrochloride (HCI) Treatment
- Keywords
- Recurrent Anaplastic Astrocytoma, Mixed Malignant Glioma, Oligodendroglioma, Irinotecan, Brain tumor, Nitrosoureas, Brain and nervous system
- Medical subject headings
- Astrocytoma, Glioma, Oligodendroglioma, Brain Neoplasms, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan Hydrochloride (HCI) TreatmentDrug
Also called CPT-11, CAMPTOSAR, Irinotecan HCL
Irinotecan injections. Irinotecan hydrochloride [CPT-11; CAMPTOSAR] is an antineoplastic agent of the topoisomerase I inhibitor class. The drug is supplied in amber vials and appears as a pale yellow transparent aqueous solution. Two vial sizes are available: 2 mL vials containing 40 mg of drug and 5 mL vials containing 100 mg of drug. A treatment cycle was 21 days. Patients were treated for a minimum of 3 cycles (doses) of CPT-11 or until their disease progressed.
Continued Irinotecan Hydrochloride (HCI) TreatmentDrug
Also called CPT-11, CAMPTOSAR, Irinotecan HCL
For patients responding to treatment, therapy could have continued beyond 18 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan Treatment | Experimental | Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes. Receives: Drug: Irinotecan Hydrochloride (HCI) Treatment; Drug: Continued Irinotecan Hydrochloride (HCI) Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Objective Response After 3 Cycles of Treatment
The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.
Measured: 3 cycles (21 day cycles)
Secondary outcomes (4)
Overall Survival at 6 Months
Patients surviving 6 months after treatment end
Measured: 6 months post treatment end
Progression Free Survival
Patients surviving at one year post treatment end
Measured: 1 year post treatment end
Frequency and Severity of Toxicity
Toxicities assessed through 3 months
Measured: 3 months
Overall Survival at 12 Months
Patients surviving 12 months after last dose of drug
Measured: 12 months post treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startFeb 2006
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Principal Investigator left Moffitt and study had low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Pan, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360828
- Sponsor's protocol ID
- MCC-14633
- Status last verified
- Nov 2011
- First submitted
- 3 Aug 2006
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Irinotecan HCI in Patients With Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas
- ClinicalTrials.gov ID
- NCT00360828
- Acronym / sponsor ID
- MCC-14633
- Conditions
- Astrocytoma, Glioma, Oligodendroglioma
- Keywords
- Recurrent Anaplastic Astrocytoma, Mixed Malignant Glioma, Oligodendroglioma, Irinotecan, Brain tumor, Nitrosoureas, Brain and nervous system
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left Moffitt and study had low accrual.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Aug 2006 (estimated)
- Results
- Posted 9 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine.
At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.
Detailed description
Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11) in patients with recurrent anaplastic astrocytomas (AA), mixed malignant glioma, and oligodendrogliomas (OA). Patients were to be stratified by tumor histology and treated with CPT-11 every 21 days (treatment cycle).
Baseline data (collected <14 days) was to consist of a neurological/oncological history, neurological examination, height, weight, performance status, Quality Of Life FACT-L questionnaire, laboratory studies to include complete blood count (CBC), differential, platelets, prothrombin time (PT), complete metabolic panel (CMP), Lactose dehydrogenase (LDH), and a pregnancy test, as well as a cranial Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) with and without contrast (to measure or evaluate the size and location of the tumor before treatment).
Administered every 21 days was a dose of irinotecan (CPT-11), zofran/Kytril/Anzemet, decadron, and intravenous (IV) atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.
Between days 15-21 (within 7 days of next scheduled CPT-11 treatment) the following tests were to be repeated - a neurological/oncological history and neurological examination, weight, blood drawn (CMP, LDH), performance status, and Quality Of Life FACT-L questionnaire. Also, a MRI (Cranial CT/MRI with and without contrast) was to be performed for tumor assessments at week 9, 18, 27, 36, and after every nine weeks thereafter until progression. Response was to be measured by a reduction in tumor size.
These supportive therapies were provided as necessary:
- Antiemetic Therapy
- Anticholinergics
- Loperamide (Imodium®)
- Growth Factors
- Other Concomitant Medications
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan Treatment | Experimental | Drug: Irinotecan Hydrochloride (HCI) Treatment, Drug: Continued Irinotecan Hydrochloride (HCI) TreatmentParticipants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histological or neuroradiographic documented recurrent glioma defined as an anaplastic astrocytoma, mixed malignant glioma or oligodendroglioma. All patients must have had prior pathologic confirmation of primary tumor histology.
- Patients must be > than or equal to 18 years old.
- Patients must have a Karnofsky performance score (KPS) of > or equal to 50
- Measurable disease per MacDonald criteria is required
- Patients must have a predicted life expectancy of at least 12 weeks
Key exclusion criteria (14 listed)
- Patients have evidence of leptomeningeal spread of disease.
- Patients having been treated with 2 or more salvage regimens.
- Pregnant or breast-feeding women. With the exception of post-menopausal or infertile women, a negative blood test for pregnancy is mandatory before entry on study. Fertile persons refusing to use adequate contraceptives may not participate.
- Patients with a history of irritable bowel disease, irritable bowel syndrome, chronic diarrhea or presence of a bowel obstruction.
- Patients with a second active malignancy or diagnosis of other cancer within 3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.
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 Hydrochloride (HCI) TreatmentAlso: CPT-11, CAMPTOSAR, Irinotecan HCLIrinotecan injections. Irinotecan hydrochloride [CPT-11; CAMPTOSAR] is an antineoplastic agent of the topoisomerase I inhibitor class. The drug is supplied in amber vials and appears as a pale yellow transparent aqueous solution. Two vial sizes are available: 2 mL vials containing 40 mg of drug and 5 mL vials containing 100 mg of drug. A treatment cycle was 21 days. Patients were treated for a minimum of 3 cycles (doses) of CPT-11 or until their disease progressed. | Drug | Irinotecan Treatment |
| Continued Irinotecan Hydrochloride (HCI) TreatmentAlso: CPT-11, CAMPTOSAR, Irinotecan HCLFor patients responding to treatment, therapy could have continued beyond 18 cycles. | Drug | Irinotecan Treatment |
Primary outcome
Number of Participants With Objective Response After 3 Cycles of Treatment
Time frame: 3 cycles (21 day cycles)
The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.
4 secondary outcomes
Overall Survival at 6 Months
Time frame: 6 months post treatment end
Progression Free Survival
Time frame: 1 year post treatment end
Frequency and Severity of Toxicity
Time frame: 3 months
Overall Survival at 12 Months
Time frame: 12 months post treatment end
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Moffitt Cancer Center Clinical Trials 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.
Edward Pan, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan Hydrochloride (HCI) Treatment and Continued Irinotecan Hydrochloride (HCI) Treatment in people with Astrocytoma and Glioma, run by H. Lee Moffitt Cancer Center and Research Institute 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 17 inclusion and 14 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: stopped early, as of the sponsor's last update on 23 Mar 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Objective Response After 3 Cycles of Treatment (time frame: 3 cycles (21 day cycles)). 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 23 Mar 2017.