A Phase 2 interventional study of Irinotecan and Panitumumab in Malignant Glioma of Brain, sponsored by Annick Desjardins. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-04.
Sponsored by Annick Desjardins · Phase 2, Interventional, and Treatment
This is a phase II study of the combination of panitumumab with irinotecan in malignant glioma patients. The primary objective of the study is to determine the activity of the combination of panitumumab with irinotecan as measured by 6-month progression-free survival. Secondary objectives include the following- to determine the safety of panitumumab in combination with irinotecan in patients with malignant glioma; to determine the effect of panitumumab in combination with irinotecan on corticosteroid dose for each patient; to explore any relationship between epidermal growth factor receptor (EGF-R) mutational analysis and efficacy or toxicity; and, to determine the response rate and overall survival of recurrent glioblastoma (GBM) patients treated with panitumumab in combination with irinotecan.
The patients will have histologically documented grade 4 malignant gliomas (glioblastoma multiforme or gliosarcoma) that have failed at least one prior chemotherapy regimen and all patients will have received radiation therapy. This study will investigate second or greater line of therapy for recurrent grade 4 malignant glioma. The patient population will include 32 patients.
The patients will undergo a baseline magnetic resonance imaging (MRI) as well as a MRI after every six-week cycle to determine response and progression. After 16 patients with recurrent GBM are treated, an interim analysis will be conducted. The most common side effects associated with panitumumab have been dermatological (skin) problems such as erythema (redness of the skin), acneiform rash (skin eruptions of the face), skin exfoliation, pruritus (itching), skin fissures (skin tears), xerosis (dryness of the eye, skin, or mouth), and rash. The most common side effects associated with irinotecan have been decreased blood counts of platelets (increased risk of bleeding), white blood cells (increased risk of infection), red blood cells (anemia); diarrhea, constipation, nausea, vomiting, tiredness, fever, mouth sores, dehydration (excessive loss of body fluids), rash, itching, changes in skin color, swelling, numbness, tingling, dizziness, confusion, low blood pressure, sweating, hot flashes, hair loss, inflammation of the liver, flu-like symptoms, decreased urine output, shortness of breath, and pneumonia (inflammatory disease of the lungs).
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's enrollment of 16 is below the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →Annick Desjardins is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Panitumumab-Specific Concerns:
[Subjects meeting any of the following criteria are ineligible for study entry]
Drug: Irinotecan · Drug: Panitumumab
Irinotecan: for those patients on an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. For those not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment on both drugs will continue until tumor progression or unacceptable toxicity.
Also known as: Camptosar, CPT-11
Panitumumab, 6 mg/kg, as an intravenous infusion every other week. Treatment on both drugs will continue until tumor progression or unacceptable toxicity.
Also known as: Vectibix
6-month Progression-free Survival (PFS)
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), and 3) concomitant steroid use (as reported by the investigator).
Time frame: 6 months
One-Year Overall Survival
Percentage of participants surviving 12 months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of the death due to any cause.
Time frame: 1 year
Safety of Panitumumab in Combination With Irinotecan
Number of participants experiencing a toxicity ≥ grade 3 as graded per CTCAE v.3.0
Time frame: 16 months
Effect of Panitumumab in Combination With Irinotecan on Corticosteroid Dose
Average change in corticosteroid dose from baseline to the end of cycle 1.
Time frame: Baseline and Day 29
Relationship Between Epidermal Growth Factor Receptor (EGF-R) Mutational Analysis and Efficacy or Toxicity
Number of participants with an abnormal fluorescence in situ hybridization (FISH) interpretation that 1) survived \< 6 months and 2) experienced a ≥ grade 3 toxicity as graded per CTCAE v.3.0
Time frame: 16 months
Objective Response Rate
Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria. A complete response is defined as the disappearance of all enhancing rumor and mass effect, off all corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. A partial response is defined as greater than or equal to 50% reduction in tumor size on MR (magnetic resonance) / CT(computed tomography) by bi-dimensional measurement on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.
Time frame: 16 months
Median Overall Survival (OS)
Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Time frame: 18 months
| Milestone | Panitumumab and Irinotecan |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), and 3) concomitant steroid use (as reported by the investigator).
| percentage of participants | Panitumumab and Irinotecan |
|---|---|
| 6-month Progression-free Survival (PFS) | 12.5 (2.1 to 32.8) |
Percentage of participants surviving 12 months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of the death due to any cause.
| percentage of participants | Panitumumab and Irinotecan |
|---|---|
| One-Year Overall Survival | 12.5 (2.1 to 32.8) |
Number of participants experiencing a toxicity ≥ grade 3 as graded per CTCAE v.3.0
| participants | Panitumumab and Irinotecan |
|---|---|
| Safety of Panitumumab in Combination With Irinotecan | 10 |
Average change in corticosteroid dose from baseline to the end of cycle 1.
| mg | Panitumumab and Irinotecan |
|---|---|
| Effect of Panitumumab in Combination With Irinotecan on Corticosteroid Dose | NA |
Number of participants with an abnormal fluorescence in situ hybridization (FISH) interpretation that 1) survived \< 6 months and 2) experienced a ≥ grade 3 toxicity as graded per CTCAE v.3.0
| participants | Panitumumab and Irinotecan |
|---|---|
| Abnormal FISH Interpretation & Survived <6 months | NA |
| Abnormal FISH Interpretation & ≥ grade 3 toxicity | NA |
Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria. A complete response is defined as the disappearance of all enhancing rumor and mass effect, off all corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. A partial response is defined as greater than or equal to 50% reduction in tumor size on MR (magnetic resonance) / CT(computed tomography) by bi-dimensional measurement on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.
| participants | Panitumumab and Irinotecan |
|---|---|
| Objective Response Rate | 0 |
Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
| months | Panitumumab and Irinotecan |
|---|---|
| Median Overall Survival (OS) | 4.6 (4.0 to 5.8) |
Collected over 16 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Panitumumab and Irinotecan | — | 1/16 (6.3%) | 16/16 (100%) |
| Event | Panitumumab and Irinotecan |
|---|---|
| Intracranial hemorrhageNervous system disorders | 1/16 |
| Ischemia cerebrovascularNervous system disorders | 1/16 |
| SeizureNervous system disorders | 1/16 |
| Event | Panitumumab and Irinotecan |
|---|---|
| FatigueGeneral disorders | 13/16 |
| Rash acneiformSkin and subcutaneous tissue disorders | 9/16 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 9/16 |
| ConstipationGastrointestinal disorders | 5/16 |
| NauseaGastrointestinal disorders | 5/16 |
| SeizureNervous system disorders | 5/16 |
| VomitingGastrointestinal disorders | 4/16 |
| Nail infectionInfections and infestations | 4/16 |
| AnorexiaMetabolism and nutrition disorders | 4/16 |
| "Musculoskeletal and connective tissue disorder - Other, specify: Fall"Musculoskeletal and connective tissue disorders | 4/16 |
| Age Continuous(years) | Panitumumab and Irinotecan |
|---|---|
| Mean | 48.73 ± 14.58 |
| Sex: Female, Male(Participants) | Panitumumab and Irinotecan |
|---|---|
| Female | 3 |
| Male | 13 |
This study is terminated, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Annick Desjardins