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Sunitinib in Treating Patients With Recurrent Malignant Glioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00713388
  Purpose

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with recurrent malignant glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: sunitinib malate
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Sunitinib Sunitinib malate Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Sunitinib in the Treatment of Recurrent Malignant Glioma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 6-month progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between response to treatment with sunitinib malate and changes in brain FDG-PET and perfusion MRI [ Designated as safety issue: No ]
  • Health-related quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: April 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the 6-month progression-free survival of patients with recurrent malignant glioma who are VEGF therapy-naïve and treated with sunitinib malate.
  • To determine the 6-month progression-free survival of patients who are bevacizumab-resistant and treated with sunitinib malate.

Secondary

  • To correlate changes in brain FDG-PET and perfusion MRI with response to therapy and clinical outcome.
  • To assess the impact of sunitinib malate on health-related quality of life in these patients.

OUTLINE: Patients are stratified according to prior treatment with bevacizumab (yes vs no) and disease histology (glioblastoma multiforme or gliosarcoma vs anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic mixed oligoastrocytoma).

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Health-related quality of life is assessed at baseline, every 4 weeks during treatment, and within 2 weeks after completion of treatment.

After completion of study treatment, patients are followed within 2 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed intracranial malignant glioma, including any of the following subtypes:

    • Glioblastoma multiforme
    • Gliosarcoma
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Malignant astrocytoma, not otherwise specified
  • Disease progression after prior treatment with radiotherapy and temozolomide, as evidenced by contrast-enhanced perfusion MRI or CT scan within the past 14 days

    • Steroid dose must be stable for ≥ 5 days
    • Patients who received prior treatment with stereotactic radiosurgery must demonstrate true tumor progression by FDG-PET or magnetic resonance spectroscopy imaging

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy > 8 weeks
  • Total leukocyte count ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL (transfusion allowed)
  • Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 1.5 times ULN
  • Serum calcium ≤ 12.0 mg/dL
  • PT ≤ 1.5 times ULN
  • INR ≤ 1.5
  • QTc interval ≤ 500 msec by EKG
  • Ejection fraction ≥ 50% by echocardiogram at baseline OR < 20% decrease from a prior echocardiogram
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
  • No other malignancy that has required treatment within the past 12 months and/or is expected to require treatment within the next 12 months, except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No stroke, unstable angina, or myocardial infarction within the past 6 months
  • No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg) while on antihypertensive medications
  • No serious cardiac arrhythmia requiring medication
  • No New York Heart Association class II-IV congestive heart failure
  • No active infection
  • No serious or non-healing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 28 days
  • No bleeding diathesis or coagulopathy
  • No other significant active cardiac, hepatic, renal, or psychiatric disease
  • No other significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or that would compromise the patient's ability to tolerate study therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy, including surgery
  • Prior recent resection of recurrent or progressive tumor allowed

    • Residual disease after resection of recurrent tumor is not required
  • More than 6 weeks since prior bevacizumab

    • Patient must have demonstrated radiographic disease progression during treatment
  • No other prior therapy directed against VEGF (e.g., sorafenib, pazopanib, vandetanib, or cediranib)
  • At least 4 weeks since prior radiotherapy
  • At least 2 weeks since prior investigational agents
  • At least 2 weeks since prior vincristine
  • At least 6 weeks since prior nitrosoureas
  • At least 3 weeks since prior procarbazine
  • At least 1 week since prior noncytotoxic agents, (e.g., interferon, tamoxifen, thalidomide, or isotretinoin)
  • At least 4 weeks since other prior cytotoxic therapy
  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior core biopsy
  • More than 2 weeks since prior and no concurrent enzyme-inducing anti-epileptic drugs (EIAEDs), including any of the following:

    • Carbamazepine
    • Oxcarbazepine
    • Phenytoin
    • Fosphenytoin
    • Phenobarbital
    • Primidone
  • More than 2 weeks since prior and no concurrent potent CYP3A4 inhibitors, including any of the following:

    • All HIV protease inhibitors
    • Clarithromycin
    • Fluoxetine
    • Nefazodone
    • Itraconazole
    • Ketoconazole
    • Fluconazole
    • Diltiazem
    • Erythromycin
    • Fluvoxamine
    • Grapefruit juice
    • Mibefradil
    • Verapamil
  • More than 2 weeks since prior and no concurrent potent CYP3A4 inducers, including any of the following:

    • Rifapentine
    • Rifampin
    • St. John's wort
    • Modafinil
  • No concurrent anti-coagulation or anti-platelet medication, including aspirin, NSAIDs, or COX-2 inhibitors
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent major surgery
  • No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713388

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Principal Investigator: Teri N. Kreisl, MD NCI - Neuro-Oncology Branch
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000599821, NCI-08-C-0168, NCI-P07336
Study First Received: July 10, 2008
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00713388  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult anaplastic oligodendroglioma
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
adult anaplastic astrocytoma
recurrent adult brain tumor
adult mixed glioma

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Central Nervous System Neoplasms
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Sunitinib
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Nervous System Diseases
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 14, 2009