Overview

Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases

Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gadolinium texaphyrin may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation. It is not yet known whether giving gadolinium texaphyrin with radiation therapy is more effective than radiation therapy alone in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without gadolinium texaphyrin in treating patients who have brain metastases.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pharmacyclics LLC.
Treatments:
Motexafin gadolinium
Criteria
DISEASE CHARACTERISTICS: Histologically proven solid tumor with parenchymal brain
metastasis Solitary metastasis eligible only if refused surgery or surgical resection
deemed inappropriate No leptomeningeal metastases or subarachnoid spread of tumor No small
cell lung cancer, germ cell tumors, lymphoma, or leukemia No liver metastases, unless from
breast cancer No more than 1 site of extracranial metastases (multiple bone or lung
metastases count as one site), unless from breast cancer Hormone receptor status: Not
specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance
status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater
than 2 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN Renal:
Creatinine no greater than 2.0 mg/mL Other: No history of porphyria No history of G6PD
deficiency HIV negative No other major medical illnesses No major psychiatric impairment
Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No chemotherapy
during and for 2 weeks after gadolinium texaphyrin therapy Endocrine therapy: Concurrent
hormonal therapy allowed Radiotherapy: No prior cranial radiation, including prior
stereotactic radiosurgery No plan for radiosurgery or radiation boost following whole brain
radiotherapy Concurrent radiotherapy allowed to other sites, except kidneys and liver
Surgery: No prior subtotal or total resection of brain metastases (except biopsies)