Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma

NCT00354068 | Completed Phase 1

• 4 other identifiers: Pro00004364DUMC-5514-06-1R2NOVARTIS-DUMC-5514-06-1R2CDR0000483760
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving imatinib mesylate together with temozolomide may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with temozolomide in treating patients with malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic oligodendroglioma; adult giant cell glioblastoma; adult gliosarcoma; adult mixed glioma; adult anaplastic astrocytoma; recurrent adult brain tumor; adult glioblastoma

Outcome Measures

Primary Outcomes (5)

• Maximum tolerated dose

• Dose-limiting toxicity

• Safety and tolerability

• Pharmacokinetics

• Anti-tumor activity

Interventions

imatinib mesylate DRUG

temozolomide DRUG

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma * Any of the following subtypes: * Glioblastoma multiforme * Gliosarcoma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic oligoastrocytoma * Previous histologic diagnosis of a lower grade of glioma allowed if there is histologic evidence of progression to a diagnosis of malignant glioma * Multifocal disease allowed * Must have undergone prior conventional external-beam radiation therapy * Stable disease, disease recurrence, or relapsed disease * Must not have received any systemic therapy for this recurrence or relapse * No prior progressive disease * No central/systemic fluid collections (pericardial effusion, pulmonary effusion, ascites) ≥ grade 2 * No evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post-operative grade 1 hemorrhage PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Absolute neutrophil count \> 1,500/mm³ * Hemoglobin \> 9 g/dL * Platelet count \> 100,000/mm³ * AST and ALT \< 2.5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * Creatinine \< 1.5 times ULN * No chronic renal disease * No active uncontrolled infection * No uncontrolled diabetes * No excessive risk of bleeding, as defined by occurrence of any of the following: * Stroke within the past 6 months * History of CNS or intraocular bleed * Septic endocarditis * No history of labile hypertension * No congestive heart failure * No poorly controlled hypertension * No myocardial infarction within the past 6 months * No history of poor compliance with antihypertensive regimen * No other severe and/or uncontrolled medical disease that would preclude study participation * No peripheral edema ≥ grade 2 * No gastrointestinal bleeding * No gross hematuria * No other active systemic bleeding * Patients must not have experienced toxicity ≥ grade 3 with prior treatment with either temozolomide or imatinib mesylate * No other primary malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix or other cancer not currently clinically significant nor requiring active interventions PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy * Prior surgical resection(s) allowed * At least 2 weeks since prior surgery * At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) * At least 2 weeks since prior external-beam radiotherapy * At least 2 weeks since prior investigational drugs * More than 1 week since prior biologic, immunotherapeutic, or cytostatic agents * No concurrent warfarin

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Reardon DA, Desjardins A, Vredenburgh JJ, Sathornsumetee S, Rich JN, Quinn JA, Lagattuta TF, Egorin MJ, Gururangan S, McLendon R, Herndon JE 2nd, Friedman AH, Salvado AJ, Friedman HS. Safety and pharmacokinetics of dose-intensive imatinib mesylate plus temozolomide: phase 1 trial in adults with malignant glioma. Neuro Oncol. 2008 Jun;10(3):330-40. doi: 10.1215/15228517-2008-003. Epub 2008 Mar 21.

  PMID: 18359865 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Oligodendroglioma; Glioblastoma; Gliosarcoma; Glioma; Astrocytoma; Brain Neoplasms

Interventions

Imatinib Mesylate; Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Dacarbazine; Triazenes; Imidazoles; Azoles

Study Officials

• David A. Reardon, MD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 20, 2006
• Study Start: July 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 28, 2013

Record last verified: 2013-03

Locations

US (1)