Clinical trial NCT00498927: Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
Official title: A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent adult brain tumor
adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma
adult anaplastic astrocytoma
adult diffuse astrocytoma
adult pilocytic astrocytoma
adult subependymal giant cell astrocytoma
adult anaplastic ependymoma
adult ependymoma
adult myxopapillary ependymoma
adult subependymoma
adult anaplastic oligodendroglioma
adult oligodendroglioma
adult brain stem glioma
adult mixed glioma
adult pineal gland astrocytoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Weill Medical College of Cornell University
name: Schering-Plough
First posted: 2007-07-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.

Detailed description: OBJECTIVES:

Primary

* Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide.

Secondary

* Determine the overall survival of patients treated with this drug.

OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)

Eligibility criteria: DISEASE CHARACTERISTICS:

* Pathologically diagnosed glioblastoma multiforme or other malignant glioma

  * Recurrent disease
* Must have received prior temozolomide

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* SGOT ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 2 times ULN
* Bilirubin ≤ 2 times ULN
* No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin
* No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment
* No medical condition that precludes swallowing pills
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from all prior therapy

Primary outcomes:
measure: Progression-free Survival (PFS) Rate at 6 Months
timeFrame: at 6 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Antonio Omuro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Thomas Kaley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omuro A, Chan TA, Abrey LE, Khasraw M, Reiner AS, Kaley TJ, Deangelis LM, Lassman AB, Nolan CP, Gavrilovic IT, Hormigo A, Salvant C, Heguy A, Kaufman A, Huse JT, Panageas KS, Hottinger AF, Mellinghoff I. Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma. Neuro Oncol. 2013 Feb;15(2):242-50. doi: 10.1093/neuonc/nos295. Epub 2012 Dec 14.