Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma

NCT00006025 | Completed Phase 1 FDA Drug

• 4 other identifiers: NABTC-9907CDR0000068037UCLA-0006095NCI-2012-02353
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant 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

irinotecan hydrochloride 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 supratentorial malignant primary glioma of one of the following subtypes: * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Mixed malignant glioma * Original histology of low-grade glioma allowed if subsequent histological confirmation of malignant glioma * Measurable recurrent or residual primary disease by MRI * Lesions with clearly defined margins * Evidence of tumor recurrence or progression by MRI or CT scan * Confirmation of true progressive disease by PET or thallium scan, magnetic resonance spectroscopy, or surgical documentation after prior interstitial brachytherapy or stereotactic radiosurgery * No more than 3 relapses after prior chemotherapy/cytotoxic therapy (including polifeprosan 20 with carmustine implant) for phase I and no more than 2 relapses for phase II PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure * No myocardial infarction within the past 6 months * No serious uncontrolled cardiac arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No mental incapacitation * HIV negative * No AIDS-related disease * No significant ongoing alcoholism or substance abuse * No severe nonmalignant systemic disease * No active infection * No other severe disease that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior interferon or thalidomide and recovered * No concurrent anticancer immunotherapy * No concurrent sargramostim (GM-CSF) * No concurrent prophylactic filgrastim (G-CSF) during first course of study therapy Chemotherapy: * See Disease Characteristics * Recovered from prior chemotherapy * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosourea) * Prior radiosensitizers allowed * No prior temozolomide or irinotecan * No other concurrent anticancer chemotherapy Endocrine therapy: * At least 1 week since prior tamoxifen and recovered * No concurrent anticancer hormonal therapy * Phase II: * Non-increasing dose of corticosteroids allowed Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No concurrent anticancer radiotherapy Surgery: * See Disease Characteristics * At least 1-3 weeks since prior surgical resection and recovered Other: * At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) and recovered * Concurrent enzyme-inducing anti-epileptic drugs with or without steroids allowed * No concurrent valproic acid as a single agent * No concurrent medication that would preclude study (e.g., nonsteroidal immunosuppressive agents) * No other concurrent investigational drugs * No concurrent participation in other clinical study

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 (9)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, 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

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

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)

• Loghin ME, Prados MD, Wen P, Junck L, Lieberman F, Fine H, Fink KL, Metha M, Kuhn J, Lamborn K, Chang SM, Cloughesy T, DeAngelis LM, Robins IH, Aldape KD, Yung WK. Phase I study of temozolomide and irinotecan for recurrent malignant gliomas in patients receiving enzyme-inducing antiepileptic drugs: a north american brain tumor consortium study. Clin Cancer Res. 2007 Dec 1;13(23):7133-8. doi: 10.1158/1078-0432.CCR-07-0874.

  PMID: 18056194 RESULT

MeSH Terms

Conditions

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

Interventions

Irinotecan; 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)

Camptothecin; Alkaloids; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Wai-Kwan A. Yung, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: January 5, 2001
• Primary Completion: January 10, 2005
• Study Completion: December 1, 2007
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

US (9)