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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 (P04601)

Primary Purpose

Glioma, Astrocytoma, Oligodendroglioma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (European Organization for Research & Treatment of Cancer/National Cancer Institute of Canada) protocol.
  • Evidence of progression confirmed radiologically (CT [computed tomography] or MRI [magnetic resonance imaging]).
  • 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 [beta human chorionic gonadotropin]) 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 [aspartate aminotransferase]) or ALAT (ALT [alanine aminotransferase) >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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Temozolomide

    Arm Description

    Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
    Progression-free survival as determined by Kaplan-Meier method.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 24, 2006
    Last Updated
    May 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00392171
    Brief Title
    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 (P04601)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 9, 2006 (Actual)
    Primary Completion Date
    September 15, 2009 (Actual)
    Study Completion Date
    September 15, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    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/m^2) 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/m^2).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Temozolomide
    Arm Type
    Experimental
    Arm Description
    Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
    Intervention Type
    Drug
    Intervention Name(s)
    Temozolomide
    Other Intervention Name(s)
    SCH 52365
    Intervention Description
    Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
    Description
    Progression-free survival as determined by Kaplan-Meier method.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 (European Organization for Research & Treatment of Cancer/National Cancer Institute of Canada) protocol. Evidence of progression confirmed radiologically (CT [computed tomography] or MRI [magnetic resonance imaging]). 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 [beta human chorionic gonadotropin]) 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 [aspartate aminotransferase]) or ALAT (ALT [alanine aminotransferase) >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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    20308655
    Citation
    Perry JR, Belanger K, Mason WP, Fulton D, Kavan P, Easaw J, Shields C, Kirby S, Macdonald DR, Eisenstat DD, Thiessen B, Forsyth P, Pouliot JF. Phase II trial of continuous dose-intense temozolomide in recurrent malignant glioma: RESCUE study. J Clin Oncol. 2010 Apr 20;28(12):2051-7. doi: 10.1200/JCO.2009.26.5520. Epub 2010 Mar 22. Erratum In: J Clin Oncol. 2010 Jul 20;28(21):3543.
    Results Reference
    result

    Learn more about this trial

    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 (P04601)

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