Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma

NCT00010049 | Completed Phase 1 FDA Drug

• 4 other identifiers: NABTC-9908CDR0000068437NCI-01-C-0243UCLA-0101024
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 11

Brief Summary

RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrent glioma and meningioma. PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult meningioma; adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; adult pilocytic astrocytoma; adult subependymoma; adult grade III meningioma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

imatinib mesylate DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or unresectable malignant glioma * Glioblastoma multiforme (phase I only) * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Gliosarcoma * Low-grade histology with subsequent diagnosis of malignant glioma allowed (phase I only) OR * Histologically confirmed recurrent or unresectable benign or malignant meningioma (phase I only) * No prior intracranial hemorrhage * Failed prior radiotherapy * Progressive or recurrent disease by MRI or CT scan and/or resection * PET or thallium scan, MR spectroscopy, or surgical documentation required in patients who have received prior interstitial brachytherapy or stereotactic radiosurgery * Stable dose of steroids for 5-7 days prior to MRI or CT scan PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT less than 2 times ULN * No significant hepatic disease Renal: * Creatinine less than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No significant renal disease Cardiovascular: * No significant cardiac disease * No deep venous or arterial thrombosis within the past 6 weeks Pulmonary: * No pulmonary embolism within the past 6 weeks Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for up to 6 months after study participation * No other serious concurrent medical illness * No serious active infection * No concurrent disease that would obscure toxicity or alter drug metabolism * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior interferon or thalidomide and recovered * No concurrent immunotherapy * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: * Recovered from prior chemotherapy * At least 4 weeks since prior cytotoxic therapy * At least 2 weeks since prior vincristine * At least 6 weeks since prior nitrosoureas * At least 4 weeks since prior temozolomide * At least 3 weeks since prior procarbazine * Prior polifeprosan 20 with carmustine implant (Gliadel wafer) allowed * Prior radiosensitizers allowed * No other concurrent chemotherapy * Phase I only: * Prior chemotherapy required for anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic mixed oligoastrocytoma * Prior treatment for up to 3 relapses allowed * Phase II only: * Prior chemotherapy not required * Prior treatment for up to 2 relapses allowed Endocrine therapy: * See Disease Characteristics * At least 1 week since prior tamoxifen and recovered * No concurrent anticancer hormonal therapy Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from prior surgical resection of recurrent or progressive disease Other: * At least 1 week since prior non-cytotoxic agents and recovered * At least 1 week since prior tretinoin and recovered * At least 2 weeks since prior drugs that affect hepatic metabolism * No other concurrent investigational 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

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0128, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0316, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-6220, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Wen PY, Yung WK, Lamborn KR, Dahia PL, Wang Y, Peng B, Abrey LE, Raizer J, Cloughesy TF, Fink K, Gilbert M, Chang S, Junck L, Schiff D, Lieberman F, Fine HA, Mehta M, Robins HI, DeAngelis LM, Groves MD, Puduvalli VK, Levin V, Conrad C, Maher EA, Aldape K, Hayes M, Letvak L, Egorin MJ, Capdeville R, Kaplan R, Murgo AJ, Stiles C, Prados MD. Phase I/II study of imatinib mesylate for recurrent malignant gliomas: North American Brain Tumor Consortium Study 99-08. Clin Cancer Res. 2006 Aug 15;12(16):4899-907. doi: 10.1158/1078-0432.CCR-06-0773.

  PMID: 16914578 RESULT

• Wen PY, Yung WKA, Lamborn K, et al.: Phase I/II study of imatinib mesylate (ST1571) for patients with recurrent malignant gliomas (NABTC 99-08). [Abstract] Neuro-Oncology 6 (4): TA-63, 385, 2004.

  RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Meningioma; Glioblastoma; Astrocytoma; Oligodendroglioma; Glioma; Glioma, Subependymal; Gliosarcoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

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

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

Study Officials

• Patrick Y. Wen, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: January 27, 2003
• Study Start: February 27, 2001
• Primary Completion: March 17, 2005
• Study Completion: August 15, 2006
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

US (11)