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)

May 15, 2017 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temozolomide
Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
Drug: Temozolomide
Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression
Other Names:
  • SCH 52365

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
Time Frame: 6 months
Progression-free survival as determined by Kaplan-Meier method.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2006

Primary Completion (Actual)

September 15, 2009

Study Completion (Actual)

September 15, 2009

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 24, 2006

First Posted (Estimate)

October 25, 2006

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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