Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy

NCT00039468 | Completed Phase 2 DMC

• 3 other identifiers: D0134DMS-15615NCI-G02-2078
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells remaining after radiation therapy. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; recurrent adult brain tumor; adult giant cell glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Response

  To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.

  2 years

Secondary Outcomes (1)

• Toxicity / QOL / Survival

  2 years

Interventions

irinotecan hydrochloride DRUG

350 or 700 mg/m2 IV every 3 weeks

Also known as: CAMPTOSAR

thalidomide DRUG

400mg/day oral

Also known as: THALOMID

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme (GBM) * Recurrent disease allowed * Evaluable disease on contrast-enhanced MRI * Prior external beam radiotherapy required PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 5 times ULN Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No significant cardiac disease * No uncontrolled high blood pressure * No unstable angina * No congestive heart failure * No myocardial infarction within the past 3 months * No serious cardiac arrhythmias Gastrointestinal: * Able to take oral medication * No gastrointestinal abnormalities * No requirement for IV alimentation * No active peptic ulcer disease Other: * No active infection * No serious uncontrolled medical disorder * No dementia or significantly altered mental status that would preclude study * No known hypersensitivity to irinotecan or thalidomide * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior thalidomide Chemotherapy: * No prior irinotecan * At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse) Endocrine therapy: * Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study * No concurrent hormonal therapy for GBM Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy for GBM Surgery: * No prior surgical procedures affecting absorption Other: * No other concurrent anticancer investigational agents for GBM * No concurrent cytochrome P450 inhibitors, including the following: * Nefazodone * Fluvoxamine * Fluoxetine * Sertraline * Paroxetine * Venlafaxine * Ketoconazole * Itraconazole * Fluconazole * Cimetadine * Clarithromycin * Diltiazem * Erythromycin * Protease inhibitors

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Related Publications (1)

• Fadul CE, Kingman LS, Meyer LP, Cole BF, Eskey CJ, Rhodes CH, Roberts DW, Newton HB, Pipas JM. A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme. J Neurooncol. 2008 Nov;90(2):229-35. doi: 10.1007/s11060-008-9655-9. Epub 2008 Jul 26.

  PMID: 18661102 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Brain Neoplasms; Gliosarcoma

Interventions

Irinotecan; Thalidomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; 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)

Camptothecin; Alkaloids; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Camilo E. Fadul, MD

  Norris Cotton Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: February 1, 2008
• Last Updated: October 27, 2011

Record last verified: 2011-10

Locations

US (2)