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Phase II Study of R115777 for the Treatment of Adults With Newly Diagnosed Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

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Trial Information

Phase II Study of R115777 for the Treatment of Adults With Newly Diagnosed Glioblastoma Multiforme


PRIMARY OBJECTIVES:

I. To estimate overall survival in newly diagnosed patients with glioblastoma multiforme
treated with R115777 before (and possibly after) radiation therapy.

SECONDARY OBJECTIVES:

I. To estimate response rate in adult patients with newly diagnosed glioblastoma multiforme
treated with R115777 prior to therapy with radiation.

II. To estimate progression free survival in newly diagnosed patients with glioblastoma
multiforme treated with R115777 before (and possibly after) radiation therapy.

III. To describe the toxicity associated with this regimen in adult patients with newly
diagnosed glioblastoma multiforme.

OUTLINE: This is a multicenter study.

INDUCTION THERAPY: Patients receive oral tipifarnib twice daily for 3 weeks. Treatment
repeats every 4 weeks for up to 3 courses.

RADIOTHERAPY: Within 14 days after the completion of induction therapy, patients undergo
radiotherapy daily, 5 days a week, for 6 weeks.

MAINTENANCE THERAPY: Two weeks after the completion of radiotherapy, patients receive
additional tipifarnib as in induction therapy.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A minimum of 54 patients will be accrued for this study within 11-14
months.


Inclusion Criteria:



- Patients must have histologically confirmed supratentorial grade IV astrocytoma
(glioblastoma multiforme)

- Patients must not have received prior radiation therapy, chemotherapy, hormonal
therapy, immunotherapy or therapy with biologic agents (including immunotoxins
immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins,
TIL, LAK or gene therapy) or hormonal therapy for their brain tumor; glucocorticoid
therapy is allowed

- Patients must have measurable and contrast-enhancing tumor on the post operative,
pretreatment MRI/CT scan (within two weeks of starting treatment)

- Patients must have recovered from the immediate post-operative period and be
maintained on a stable corticosteroid regimen from the time of their baseline scan
until the start of treatment

- Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be
able to care for himself/herself with occasional help from others)

- Absolute neutrophil count >= 1500/mm^3

- Platelets >= 100,000/mm^3

- Hemoglobin >= 9 g/dl

- Creatinine =< 1.5 mg/dl

- Total bilirubin =< 2.0 mg/dl

- Transaminases =< 4 times above the upper limits of the institutional norm

- Patients must be able to provide written informed consent and must be aware of the
investigational nature of this study

- Patients with the potential for pregnancy or impregnating their partner must agree to
follow acceptable birth control methods to avoid conception; the anti-proliferative
activity of this experimental drug may be harmful to the developing fetus or nursing
infant; female patients of child-bearing potential must have a negative pregnancy
test

- Patients must have no concurrent malignancy except curatively treated basal or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast;
patients with prior malignancies must be disease-free for >= five years

- Patients must have a mini-mental state exam score (MMSE) of >= 15

Exclusion Criteria:

- Patients with serious concurrent infection or medical illness which would jeopardize
the ability of the patient to receive the chemotherapy outlined in this protocol with
reasonable safety

- Patients who are pregnant or breast-feeding

- Patients who have received prior radiation therapy, chemotherapy, hormonal therapy
(except glucocorticoids), immunotherapy or therapy with biologic agents (including
immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons,
interleukins, TIL, LAK or gene therapy) for their brain tumor

- Patients receiving concurrent investigational agents

- Patients who have received Gliadel wafer therapy may not participate in this study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

95% confidence intervals will be estimated.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Robert Lustig

Investigator Role:

Principal Investigator

Investigator Affiliation:

New Approaches to Brain Tumor Therapy Consortium

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03013

NCT ID:

NCT00058097

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Glioblastoma
  • Gliosarcoma

Name

Location

New Approaches to Brain Tumor Therapy ConsortiumBaltimore, Maryland  21231-1000