Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma

NCT00027625 | Completed Phase 1 FDA Drug

• 2 other identifiers: NABTC-0102CDR0000069049
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 11

Brief Summary

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining gefitinib with temozolomide in treating patients who have malignant primary glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

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

Interventions

gefitinib DRUG

temozolomide 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 malignant primary glioma * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Stable or progressive disease * Progressive disease after interstitial brachytherapy or stereotactic radiosurgery must be confirmed by positron emission tomography or thallium scan, magnetic resonance spectroscopy, or surgical biopsy * Prior treatment for no more than 3 prior relapses allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * WBC greater than 3,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 120,000/mm\^3 * Hemoglobin greater than 10 g/dL (transfusion allowed) Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT less than 1.5 times ULN Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No active infection * No other concurrent significant medical illness that would preclude study participation * No significant gastrointestinal risk factors (e.g., active ulcerative colitis) within the past 6 months * No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior interferon * No concurrent filgrastim (G-CSF) during the first course of study therapy Chemotherapy: * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 6 weeks since prior nitrosoureas * Prior or concurrent temozolomide allowed if there is no evidence of progression while receiving therapy Endocrine therapy: * At least 1 week since prior tamoxifen * Must be on a stable dose of corticosteroids for at least 5 days Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 1 week since prior surgical resection Other: * Recovered from all prior therapy * No prior gefitinib * At least 1 week since prior non-cytotoxic agents except radiosensitizers * At least 4 weeks since prior cytotoxic therapy * At least 4 weeks since prior investigational agents * At least 3 years since prior therapy for other malignancy * Concurrent therapeutic agents allowed at stable dosage * Concurrent enzyme-inducing anti-epileptic drugs allowed if continued during study participation

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, 48109-0752, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Simmons Cancer 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 (1)

• Prados MD, Yung WK, Wen PY, Junck L, Cloughesy T, Fink K, Chang S, Robins HI, Dancey J, Kuhn J. Phase-1 trial of gefitinib and temozolomide in patients with malignant glioma: a North American brain tumor consortium study. Cancer Chemother Pharmacol. 2008 May;61(6):1059-67. doi: 10.1007/s00280-007-0556-y. Epub 2007 Aug 11.

  PMID: 17694310 RESULT

MeSH Terms

Conditions

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

Interventions

Gefitinib; Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Michael Prados, MD

  UCSF Medical Center at Parnassus

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: January 28, 2002
• Primary Completion: March 17, 2005
• Study Completion: November 1, 2005
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

US (11)