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

Pharmacyclics

Status and phase: Completed; Phase 1

Conditions: Oligodendroglioma; Glioblastoma; Glioma; Astrocytoma; Brain Neoplasm

Treatments: Drug: Motexafin Gadolinium Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080054

PCYC-0218

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)