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)

NCT00392171 | Completed Phase 2 Results

• 1 other identifier: P04601
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Glioma; Astrocytoma; Oligodendroglioma; Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.

  Progression-free survival as determined by Kaplan-Meier method.

  6 months

Study Arms (1)

Temozolomide

EXPERIMENTAL

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

Interventions

Temozolomide DRUG

Subjects will receive temozolomide 50 mg/m\^2 for cycles of 28 days for 12 months or until progression

Also known as: SCH 52365

Temozolomide

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
• Signed informed consent form.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 20308655 RESULT

MeSH Terms

Conditions

Glioma; Astrocytoma; Oligodendroglioma; Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2006
• First Posted: October 25, 2006
• Study Start: June 9, 2006
• Primary Completion: September 15, 2009
• Study Completion: September 15, 2009
• Last Updated: June 7, 2017
• Results First Posted: May 17, 2010

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share