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The Effects of Continuous 28-Day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-Day (5/28) Treatment (P04601AM1)
This study is ongoing, but not recruiting participants.
First Received: October 24, 2006   Last Updated: March 4, 2009   History of Changes
Sponsors and Collaborators: Schering-Plough
Schering Canada, Inc.
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00392171
  Purpose

The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m2).


Condition Intervention Phase
Glioma
Astrocytoma
Oligodendroglioma
Glioblastoma
Drug: Temozolomide
Phase II

Drug Information available for: Temozolomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-Intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Survival at six months of treatment without evidence of disease progression. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall clinical benefit; Tumor response; Time to objective response; Duration of objective response; Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2006
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Temozolomide: Experimental
Temozolomide will be administered at a dose of 50mg/m2 for cycles of 28 days for 12 months or until progression.
Drug: Temozolomide
Subjects will receive temozolomide 50 mg/m2 for cycles of 28 days for 12 months or until progression

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, greater than 18 years old.
  • Surgically confirmed diagnosis of malignant glioma, specifically anaplastic glioma (anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO], anaplastic oligoastrocytoma [AOA]) or glioblastoma multiforme (GBM).
  • Must have completed at least 2 cycles (2 months) of conventional 5/28 temozolomide, with radiological evidence of progression.
  • GBM treated with concurrent chemoradiation with temozolomide according to the EORTC/NCIC protocol.
  • Evidence of progression confirmed radiologically (CT or MRI).
  • Patients must be enrolled within 2 weeks of last radiological confirmation of progression, except for patients undergoing surgical resection.
  • Patients undergoing surgical resection for recurrent disease must be enrolled within 2 weeks of the post-surgical scan.
  • Patients with no residual disease after surgery are allowed.
  • Steroids dose should have been stabilized during the last 2 weeks prior to enrollment.
  • Use of medically approved contraception in fertile males and females.
  • Women of childbearing potential must have a negative urine or serum pregnancy test (urinary excretion or serum level of bHCG) within 24 hours of inclusion in the study.
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  • Signed informed consent form.

Exclusion Criteria:

  • GBM progression during the first 2 months of adjuvant temozolomide (5/28).
  • AA progression during the first 2 months of standard temozolomide therapy (5/28).
  • Chemotherapy for the malignant glioma other than temozolomide.
  • More than one prior course of chemotherapy with temozolomide.
  • Patient evolving from anaplastic glioma to GBM following primary therapy.
  • Patient older than 70 years or who received no conventional chemoradiation regimen.
  • Patient who received radiotherapy for recurrent disease.
  • Patient with metastatic disease.
  • Known human immunodeficiency virus (HIV) infection.
  • History of non-compliance to other therapies.
  • Inadequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to study inclusion):
  • Absolute neutrophil count <=1.5 ×10^9/L;
  • Platelets <=100 ×10^9/L;
  • Hemoglobin <90 g/L;
  • Serum creatinine >=1.5 times upper limit of laboratory normal (ULN);
  • Total serum bilirubin >=1.5 times ULN;
  • ASAT (AST) or ALAT (ALT) >2.0 times ULN;
  • Alkaline phosphatase of >2.5 times ULN.
  • Known chronic hepatitis B or hepatitis C infection.
  • Any other serious medical condition, according to the medical judgment of the physician prior to inclusion in the study.
  • Any medical condition that could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
  • Other malignancies during the previous 5 years with the exception of surgically cured carcinoma in-situ of the cervix and basal cell carcinoma or non-melanoma skin cancer.
  • Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before inclusion in the study.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Schering-Plough ( Nabil Abadir, MD - Medical Director, Canada Country Operations )
Study ID Numbers: P04601
Study First Received: October 24, 2006
Last Updated: March 4, 2009
ClinicalTrials.gov Identifier: NCT00392171     History of Changes
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Disease Progression
Temozolomide
Recurrence
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Antineoplastic Agents, Alkylating
Alkylating Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Oligodendroglioma
Glioma
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009