A Phase 2 interventional study of radiation therapy and Celecoxib in Brain and Central Nervous System Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Terminated at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, Interventional, and Treatment
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are assigned to 1 of 2 groups based on anticonvulsant therapy.
Group A: Patients treated with any of the following anticonvulsant drugs that induce hepatic metabolic enzymes:
Group B: Patients treated with any of the following anticonvulsant drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug:
NOTE: *Patients receive only 1 dose on the first day of celecoxib administration.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 44 patients (22 per group) will be accrued for this study within approximately 8 months.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 35 is close to the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior immunotherapy or biologic agents for the malignancy, including any of the following:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine) celecoxib and radiation therapy will be adminstered with this arm
Radiation: radiation therapy · Drug: Celecoxib
not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate. celecoxib and radiation therapy will be adminstered with this arm
Radiation: radiation therapy · Drug: Celecoxib
Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment
Also known as: RT
Celecoxib will begin 1 week prior to RT at 400mg bid orally. One day 1 only 1 dose will be administered. Starting on day 2 and throughout treatment until progression, 2 doses will be administered at least 12 hours apart. Celecoxib will continue throughout the 6 week course of RT.
Also known as: Cox2
Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib
subjects will take one dose of celecoxib and will then have 6 hours of blood draws, day 2 subject will take 2 doses of celecoxib 8 hours apart with 2 additional blood samples, one hour apart. Subject, will continue to take 2 doses of celecoxib for 6 weeks, with a sample (PK) drawn every week prior to the first dose of the week. Comparison of Cmax of Celecoxib is reported
Time frame: First dose of celecoxib through completion of radiation, 6 weeks.
Overall Survival
duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme
Time frame: date pt started treatment to date pt last known alive
pts were enrolled on this study from October 2003 to September 2004. Pts were enrolled in an outpatient clinical setting
| Milestone | nonp450 | p450 |
|---|---|---|
| Started | 13 | 22 |
| Completed | 13 | 22 |
| Not completed | 0 | 0 |
subjects will take one dose of celecoxib and will then have 6 hours of blood draws, day 2 subject will take 2 doses of celecoxib 8 hours apart with 2 additional blood samples, one hour apart. Subject, will continue to take 2 doses of celecoxib for 6 weeks, with a sample (PK) drawn every week prior to the first dose of the week. Comparison of Cmax of Celecoxib is reported
| (ng/ml) | nonp450 | p450 |
|---|---|---|
| Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib | 1752 ± 550 | 1813 ± 813 |
duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme
| months | p450 ( +EIASD) | nonp450 (-EIASD) |
|---|---|---|
| Overall Survival | 11.5 (8 to 16) | 16 (6 to 18) |
Collected over until pts progressed off treatment - in this study approximately avg 117 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| P450 ARM | — | 0/22 (0%) | 22/22 (100%) |
| Non P450 ARM | — | 0/13 (0%) | 13/13 (100%) |
| Event | P450 ARM | Non P450 ARM |
|---|---|---|
| fatigueGeneral disorders | 7/22 | 6/13 |
| cushingoid appearanceEndocrine disorders | 5/22 | 5/13 |
| dyspepsia/heartburnGastrointestinal disorders | 4/22 | 5/13 |
| HyperglycemiaMetabolism and nutrition disorders | 7/22 | 2/13 |
| anorexiaMetabolism and nutrition disorders | 5/22 | 4/13 |
| headacheNervous system disorders | 6/22 | 4/13 |
| nauseaGastrointestinal disorders | 5/22 | 4/13 |
| PlateletsInvestigations | 3/22 | 4/13 |
| Hemoglobin / anemiaBlood and lymphatic system disorders | 6/22 | 2/13 |
| alopeciaSkin and subcutaneous tissue disorders | 2/22 | 3/13 |
| Age, Continuous(years) | p450 ( +EIASD) | nonp450 (-EIASD) | Total |
|---|---|---|---|
| Mean | 58 ± 12 | 56 ± 17 | 57 ± 26 |
| Sex: Female, Male(Participants) | p450 ( +EIASD) | nonp450 (-EIASD) | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 14 | 6 | 20 |
| Karnofsky Perfomance Status (KPS)(scores on a scale) | p450 ( +EIASD) | nonp450 (-EIASD) | Total |
|---|---|---|---|
| Mean | 88 ± 11 | 83 ± 9 | 86 ± 10 |
| Mini Mental State Exam Score(scores on a scale) | p450 ( +EIASD) | nonp450 (-EIASD) | Total |
|---|---|---|---|
| Mean | 28 ± 4 | 28 ± 3 | 28 ± 3 |
| Corticosteroid therapy(Participants) | p450 ( +EIASD) | nonp450 (-EIASD) | Total |
|---|---|---|---|
| Yes | 18 | 11 | 29 |
| No | 4 | 2 | 6 |
| Prior Surgery(Participant) | p450 ( +EIASD) | nonp450 (-EIASD) | Total |
|---|---|---|---|
| Craniotomy | 21 | 10 | 31 |
| Biopsy | 1 | 3 | 4 |
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins