A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Motexafin Gadolinium Injection

About this trial

This is an interventional treatment trial for Glioma focused on measuring Malignant Glioma, Glioblastoma multiforme, GBM, Anaplastic astrocytoma, AA, Anaplastic oligodendroglioma, Anaplastic mixed glioma, Brain tumor, Brain neoplasm, Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least 18 years old Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma) ECOG performance status score of 0, 1, or 2 Each patient must sign a study-specific informed consent form Exclusion Criteria: Laboratory values of: Absolute neutrophil count < 2000/µL Platelet count < 100,000/µL AST or ALT > 2 x the upper limit of normal (ULN) Alkaline phosphatase > 5 x ULN Bilirubin > 2 x ULN Creatinine > 2.0 mg/µL and Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period Women who are pregnant or lactating

Sites / Locations

Barrow Neurological Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00080054

First Posted

March 22, 2004

Last Updated

April 2, 2009

Sponsor

Pharmacyclics LLC.

1. Study Identification

Unique Protocol Identification Number

NCT00080054

Brief Title

A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas

Official Title

Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Pharmacyclics LLC.

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Neoplasm

Keywords

Malignant Glioma, Glioblastoma multiforme, GBM, Anaplastic astrocytoma, AA, Anaplastic oligodendroglioma, Anaplastic mixed glioma, Brain tumor, Brain neoplasm, Glioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Motexafin Gadolinium Injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: At least 18 years old Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma) ECOG performance status score of 0, 1, or 2 Each patient must sign a study-specific informed consent form Exclusion Criteria: Laboratory values of: Absolute neutrophil count < 2000/µL Platelet count < 100,000/µL AST or ALT > 2 x the upper limit of normal (ULN) Alkaline phosphatase > 5 x ULN Bilirubin > 2 x ULN Creatinine > 2.0 mg/µL and Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period Women who are pregnant or lactating

Facility Information:

Facility Name

Barrow Neurological Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.braintumor.org

Description

Related Info

URL

http://www.pcyc.com

Description

Related Info

Glioma, Glioblastoma, Astrocytoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial