Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)

NCT00684567 | Completed Phase 2 Results DMC

• 2 other identifiers: P04661JPC-05-351-22
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression free survival and response rate will also be calculated.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (3)

• Adverse Events With an Incidence of Greater Than or Equal to 20%

  Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy. Adverse events were classified under the system organ class using MedDRA-J Version 11.0.

  until 30 days after the completion of administration of monotherapy

• Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%

  Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.

  until 30 days after the completion of administration of monotherapy

• Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%

  Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.

  until 30 days after the completion of administration of monotherapy

Secondary Outcomes (2)

• Number of Participants With Progression Free Survival (PFS) for 1 Year

  1 year after the start of admininstration in the concomitant radiotherapy phase

• Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response

  1 year after the start of administration in the concomitant radiotherapy phase

Study Arms (1)

Single arm

EXPERIMENTAL

It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.

Radiation: Radiotherapy; Drug: Temozolomide

Interventions

Radiotherapy RADIATION

Radiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist of a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiation will be provided by a linear accelerator of x ray energy of 4 MV or higher.

Also known as: Irradiation, radiation therapy

Single arm

Temozolomide DRUG

During the concomitant radiotherapy phase (6 weeks), temozolomide will be administered in combination with radiotherapy, once daily at 75 mg/m2/day. Then, during the monotherapy phase, subjects will receive 6 cycles of temozolomide alone. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematologic toxicity observed and neutrophil and platelet count values. Capsules containing 5 mg, 20 mg, or 100 mg of temozolomide will be combined to achieve each subject's calculated dose.

Also known as: Temodal, Temodar, SCH 052365

Single arm

Eligibility Criteria

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

You may qualify if:

• Histopathologically confirmed newly diagnosed glioblastoma multiforme with WHO grade IV.
• Histological diagnosis must be made locally after biopsy or neurosurgical tumor resection.
• Four or more unstained tissue sections or a paraffin block must be provided to the Pathological Judgment Committee as tissue specimens.
• Initial surgery/biopsy at diagnosis performed \<=6 weeks (42 days) prior to treatment with temozolomide.
• Age: \>=18 and \<=70 years.
• ECOG performance status \<=2.
• Stable, non-increasing dose of corticosteroids over the 14 days prior to treatment with temozolomide.
• No prior chemotherapy or radiotherapy.
• Laboratory test values obtained within 14 days before initiation of administration of temozolomide must satisfy the following criteria:
• absolute neutrophil count \>= 1500/mm\^3;
• platelet count \>= 100,000/mm\^3;
• serum creatinine \<=1.5 times the upper limit of laboratory normal;
• total bilirubin \<=1.5 times the upper limit of laboratory normal;
• glutamic oxaloacetic transaminase or glutamic pyruvic transaminase \<2.5 times the upper limit of laboratory normal;
• alkaline phosphatase \< 2.5 times the upper limit of laboratory normal.

You may not qualify if:

• Extensively disseminated glioblastoma multiforme.
• Severe disorders in the heart, liver, kidney, blood, etc.
• Presence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non melanoma skin cancer.
• Women who are pregnant or lactating.
• Women who may be pregnant or who could become pregnant and do not adopt contraception method(s).
• Participation in another clinical study within 6 weeks prior to the initiation of administration of temozolomide.
• Subjects who the investigator and/or subinvestigator judged inappropriate to participate in the study.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy; Radiation; Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena; 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

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: September 27, 2005
• Primary Completion: October 31, 2007
• Study Completion: October 31, 2007
• Last Updated: June 7, 2017
• Results First Posted: March 12, 2009

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share