Status:
COMPLETED
Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
NCIC Clinical Trials Group
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and ...
Detailed Description
OBJECTIVES: Phase I * Determine the maximum tolerated dose and recommended phase II dose of lapatinib in patients with recurrent malignant glioblastoma multiforme who are taking CYP3A4 enzyme-induci...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant glioblastoma multiforme
- Recurrent or progressive disease after prior primary treatment with radiotherapy with or without adjuvant chemotherapy
- Bidimensionally measurable disease on CT scan or MRI with at least one lesion ≥ 1 cm x 1 cm
- Paraffin embedded tumor sample available
- Concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) required for phase I of the study
- Patients in phase II of the study may or may not be receiving EIAEDs
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 1.5 times ULN
- Cardiovascular
- LVEF ≥ 50% by echocardiogram or MUGA
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No unstable angina
- No active cardiomyopathy
- No cardiac arrhythmia
- No uncontrolled hypertension
- Pulmonary
- No pulmonary disease requiring oxygen
- Neurologic
- No preexisting peripheral neuropathy ≥ grade 3
- No history of significant neurologic disorder that would preclude study compliance or ability to give informed consent
- Gastrointestinal
- No upper gastrointestinal or other conditions that would preclude compliance with oral medication
- No active peptic ulcer disease
- Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor
- No immune deficiency
- No history of significant psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude study compliance or ability to give informed consent
- No other serious illness or medical condition that would preclude study participation
- No known hypersensitivity to compounds of similar chemical or biological composition to lapatinib
- No active uncontrolled or serious infection
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other hematopoietic growth factors
- Concurrent hematopoietic growth factors allowed for treatment of acute toxicity (e.g., febrile neutropenia)
- Chemotherapy
- See Disease Characteristics
- No prior chemotherapy for recurrent disease
- No more than one prior chemotherapy regimen in the adjuvant setting
- At least 6 months since prior adjuvant chemotherapy
- Endocrine therapy
- Concurrent steroids allowed provided the dose is stable for at least 14 days before study entry
- Radiotherapy
- See Disease Characteristics
- At least 6 weeks since prior radiotherapy
- Surgery
- At least 2 weeks since prior major surgery
- Other
- H2 blockers and proton pump inhibitors allowed, unless they are CYP3A4 inducers or inhibitors
- At least 7 days since prior and no concurrent administration of any of the following CYP3A4 inhibitors:
- Clarithromycin
- Erythromycin
- Troleandomycin
- Telithromycin
- Ciprofloxacin
- Norfloxacin
- Itraconazole
- Ketoconazole
- Voriconazole
- Fluconazole (≤150 mg/day allowed)
- Nefazodone
- Fluovoxamine
- Delavirdine
- Nelfinavir
- Amprenavir
- Ritonavir
- Indinavir
- Saquinavir
- Lopinavir
- Verapamil
- Diltiazem
- Aprepitant
- Grapefruit or grapefruit juice
- Bitter orange
- At least 14 days since prior and no concurrent administration of any of the following CYP3A4 inducers:
- Rifampin
- Rifabutin
- Rifapentine
- Efavirenz
- Nevirapine
- Hypericum perforatum (St. John's wort)
- Modafinil
- At least 6 months since prior and no concurrent administration of amiodarone
- Antacids (e.g., mylanta, maalox, tums, rennies) must be administered ≥ 1 hour before and ≥ 1 hour after study drug
- At least 2 days since prior and no concurrent cimetidine
- No other concurrent anti-cancer agents
- No other concurrent investigational therapy
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00099060
Start Date
December 1 2004
End Date
November 1 2007
Last Update
January 27 2014
Active Locations (6)
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1
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
2
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
3
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
4
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2