Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

• Sponsor: Marmara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00575887
• Collaborator: Schering-Plough (Industry)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 31
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma; Astrocytoma; Oligodendroglioma; Brain Tumor, Recurrent	Drug: Temozolomide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Temozolomide; 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity; Other Names: Temodal Temodar

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival at 6-months [Until progression]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient age >18 years old

• Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)

• Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging

• Karnofsky Performance Status scale >/=50 (due to brain pathology)

• Adequate hematological, renal and hepatic function

• Patients willing to participate in the study and signing the informed consent

Exclusion Criteria:

• Karnofsky Performance Status scale <50

• Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study

• Patients not suitable for follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marmara University Hospital	Istanbul		Turkey	34660

Sponsors and Collaborators

• Marmara University
• Schering-Plough

Investigators

• Study Chair: Ufuk ABACIOGLU, MD, Marmara University Hospital, Radiation Oncology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ufuk ABACIOGLU, Assoc. Prof., Marmara University
• ClinicalTrials.gov Identifier: NCT00575887
• Other Study ID Numbers: MU-RO-2005-1
• First Posted: Dec 18, 2007
• Last Update Posted: Dec 20, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Ufuk ABACIOGLU, Assoc. Prof., Marmara University: Temozolomide; Brain Tumor, Recurrent; Chemotherapy
• Additional relevant MeSH terms: Glioblastoma; Brain Neoplasms; Astrocytoma; Oligodendroglioma; Temozolomide

Study Results

Participant Flow

Arm/Group Title	Dose-Dense Temozolomide
Arm/Group Description	Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity
Period Title: Overall Study
STARTED	25
COMPLETED	25
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dose-Dense Temozolomide
Arm/Group Description	Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity
Overall Participants	25
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 80%
>=65 years	5 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50 (14)
Sex: Female, Male (Count of Participants)
Female	7 28%
Male	18 72%
Region of Enrollment (participants) [Number]
Turkey	25 100%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival at 6-months
Time Frame	Until progression

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Temozolomide
Arm/Group Description	Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity
Measure Participants	25
Number [percentage of participants]	17.3 69.2%

Adverse Events

Arm/Group Title	Temozolomide
Arm/Group Description	Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity
All Cause Mortality
	Temozolomide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Temozolomide
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Temozolomide
	Affected / at Risk (%)	# Events
Total	20/25 (80%)
Blood and lymphatic system disorders
Lymphopenia	20/25 (80%)	20
Thrombocytopenia	2/25 (8%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.