Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

ABT-888, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

Brief Summary

RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,...

Detailed Description

OBJECTIVES: Primary * To determine the maximum tolerated dose (MTD) of ABT-888 when administered in combination with radiotherapy and temozolomide in patients with newly diagnosed glioblastoma multi...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
  • Newly diagnosed disease
  • Patients enrolled in the phase I initial safety portion of the study must meet the following additional criteria:
  • Received 90% of planned radiotherapy and ≥ 80% of planned concurrent temozolomide within the past 28-49 days
  • No grade 3-4 toxicity attributed to temozolomide
  • Has undergone gadolinium MRI or contrast CT scan within the past 28 days
  • Patients enrolled in the phase I dose-escalation/phase II portion of the study must meet the following additional criteria:
  • Recovered from immediate post-operative period and maintained on a stable corticosteroid regimen (no increase in 5 days) prior to starting study treatment
  • Has undergone gadolinium MRI or contrast CT scan within the past 14 days
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 3 months
  • ANC ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
  • Total bilirubin ≤ 1.5 mg/dL
  • Transaminases ≤ 2.5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception prior to, during, and for 3 months after completion of study therapy
  • Mini Mental State Exam score ≥ 15
  • Able to swallow and retain oral medications
  • No concurrent serious infection or medical illness that would jeopardize the ability of the patient to receive study treatment with reasonable safety
  • No other malignancy within the past 5 years except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
  • No known uncontrolled seizure disorder (i.e., status epilepticus) or seizures occurring ≥ 3 times per week over the past month
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • More than 10 days since prior cytochrome P450-inducing anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
  • At least 1 week since prior biopsy or resection of tumor (for patients enrolled in the phase I dose-escalation/phase II portion of the study)
  • No prior radiotherapy, chemotherapy, immunotherapy, hormonal therapy, or biological therapy (including immunotoxins, immunoconjugates, antisense therapy, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy) for treatment of brain tumor (for patients enrolled in the phase I dose-escalation/phase II portion of the study)
  • Prior glucocorticoid therapy allowed
  • No other prior chemotherapy or investigational agents (for patients enrolled in the phase I initial safety portion of the study)
  • Prior Gliadel wafers allowed (for patients enrolled in the phase I portion of the study)
  • No prior Gliadel wafers (for patients enrolled in the phase II portion of the study)

Exclusion

    Key Trial Info

    Start Date :

    July 13 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2012

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00770471

    Start Date

    July 13 2009

    End Date

    March 1 2012

    Last Update

    June 27 2018

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    UAB Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35294-3410

    2

    UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, United States, 94115

    3

    Winship Cancer Institute of Emory University

    Atlanta, Georgia, United States, 30322

    4

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231