Study of Temozolomide to Treat Newly Diagnosed Brain Metastases

NCT00717275 | Terminated Phase 2 Results DMC

• 1 other identifier: METS-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if administering temozolomide after completion of stereotactic radiosurgery helps control existing brain metastases and prevents the developement of new brain metastases.

Conditions

Brain Metastases

Keywords

Brain Metastases; Temozolomide; Temodar; TMZ; Stereotactic Radiosurgery; SRS

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Developed Distant Brain Failure at One Year.

  1 Year

Study Arms (1)

Temozolomide

EXPERIMENTAL

Drug: Temozolomide

Interventions

Temozolomide DRUG

75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.

Also known as: Temodar, TMZ

Temozolomide

Eligibility Criteria

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

You may qualify if:

• Tumor characteristics adequate for stereotactic radiosurgery:
• newly diagnosed, previously untreated, brain metastases
• Each tumor measuring a size less than or equal to 3 cm
• No other contraindications to stereotactic radiosurgery
• Systemic parameters adequate for temozolomide following stereotactic radiosurgery:
• Histological confirmation of systemic malignancy (brain confirmation not required)
• Male or female 18 years of age or older
• Negative pregnancy test (if of childbearing potential)
• Any number of previous recurrences will be allowed
• Karnofsky Performance Status \> 60
• Hematocrit \> 30,000
• White blood cell count \> 1,500
• Platelet \> 100,000
• Absolute Neutrophil Count \> 1,000
• Bilirubin \< 1.5 x upper limits of normal

You may not qualify if:

• Karnofsky Performance Status \< 60
• Hematocrit \< 30,000
• White blood cell count \< 1,500
• Platelet \< 100,000
• Absolute Neutrophil Count \< 1,000
• Bilirubin \>1.5 x upper limits of normal
• Transaminases (ALT and AST) \> 1.5 x upper limits of normal
• Creatinine \> 1.5 x upper limits of normal
• Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis
• Germ cell, leukemia, and lymphoma histologies will be excluded
• Prior chemotherapy or radiotherapy for brain metastases (prior resection and steroids are allowed)
• Contraindications to radiosurgery or temozolomide chemotherapy
• Uncontrolled systemic malignancy
• Chemotherapy or other systemic therapy for systemic malignancy within a specified time of temozolomide initiation, depending on half-life of agent:
• Cytotoxic chemotherapy within the previous 4 weeks

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This single center study was terminated early due to slow accrual; therefore, statistical analysis of the 3 participants was not done.

Results Point of Contact

• Title: Dr. Erin M. Dunbar
• Organization: University of Florida

edunbar@neurosurgery.ufl.edu

352-273-9000

Study Officials

• Erin M Dunbar, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 1, 2012
• Results First Posted: July 12, 2012

Record last verified: 2012-07

Locations

US (1)