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Status:

COMPLETED

Gossypol (AT-101) and Temozolomide With or Without Radiation Therapy 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+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gossypol and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radia...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of gossypol (AT-101) when administered with radiotherapy (RT) and concurrent temozolomide (TMZ) in patients with newly diagnosed glio...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
  • Meets 1 of the following criteria:
  • Completed surgery within the past 6 weeks (group I)
  • Received radiotherapy and concomitant temozolomide at least 4 weeks but no more than 7 weeks prior to start of study treatment (group II)
  • Must be on a stable corticosteroid regimen (no increase for 5 days)
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 60-100%
  • Hemoglobin ≥ 10 g/dL
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤1.5 mg/dL
  • Bilirubin ≤ 1.5 mg/dL
  • ALT and AST ≤ 2.5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after completion of study treatment
  • Mini Mental State Exam score ≥ 15
  • Must be able to swallow and retain oral medication
  • No serious concurrent infection or medical illness that would preclude study participation
  • No other malignancy within the past 5 years, except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
  • No sensory neuropathy ≥ grade 2
  • No allergies to gossypol
  • No symptomatic hypercalcemia or hypercalcemia \> grade 2
  • No gastrointestinal disease including any of the following:
  • Malabsorption syndrome
  • Disease significantly affecting gastrointestinal function
  • Ulcerative colitis
  • Inflammatory bowel disease
  • Partial or complete small bowel obstruction
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from the immediate postoperative period
  • No prior radiotherapy, chemotherapy, immunotherapy, therapy with biologic agents (including immunotoxins, immunoconjugates, antisense agents, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cells or gene therapy), or hormonal therapy for this brain tumor (group I)
  • Prior glucocorticoid therapy allowed
  • No prior polifeprosan 20 with carmustine implant (Gliadel wafers) (group I)
  • No prior gossypol
  • No prior radiosurgery or brachytherapy
  • No prior resection of the stomach or small intestine
  • No other concurrent anticancer therapy (i.e., chemotherapeutics or investigational agents)
  • No concurrent cytochrome p450 enzyme-inducing anticonvulsant drugs
  • No concurrent prophylactic filgrastim (G-CSF)
  • No concurrent iron supplements
  • Nutritional supplements containing iron allowed
  • No concurrent intensity-modulated radiotherapy
  • No concurrent electron, particle, implant, or stereotactic radiosurgery boost

Exclusion

    Key Trial Info

    Start Date :

    February 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00390403

    Start Date

    February 1 2007

    Last Update

    May 3 2012

    Active Locations (8)

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

    Page 1 of 2 (8 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, United States, 35294

    2

    H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, United States, 33612-9497

    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, 21231-2410