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Motexafin Gadolinium Plus Radiation Therapy to the Brain in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00022256
First received: August 10, 2001
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of motexafin gadolinium plus radiation therapy to the brain in treating patients who have newly diagnosed glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: motexafin gadolinium
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: An Open-Label Phase II Trial to Evaluate the Safety and Pharmacokinetics of Motexafin Gadolinium and Cranial Irradiation in the Treatment of Newly Diagnosed Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: April 2001
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Assess the safety of motexafin gadolinium and cranial irradiation, in terms of dose-limiting toxicity and clinically significant adverse events, in patients with newly diagnosed glioblastoma multiforme. II. Evaluate the pharmacokinetics of this regimen in these patients. III. Determine the survival of patients treated with this regimen. IV. Assess the activities of daily living and neurological status of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive motexafin gadolinium IV over 30 minutes on days 1-5 of weeks 1 and 2, and on days 1, 3, and 5 of weeks 3-6. Patients undergo cranial irradiation on days 1-5 of weeks 1-6. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo a neurological examination and an activities of daily living questionnaire at baseline, week 10, and during follow-up visits. Patients are followed at weeks 10 and 16 and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme (GBM) Grade IV astrocytoma Located supratentorially At least 2 weeks and no more than 4 weeks since prior surgery for GBM No recurrent disease

PATIENT CHARACTERISTICS: Age: 18 and over 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 3.0 mg/dL AST and ALT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: HIV negative No history of porphyria No glucose-6-phosphate dehydrogenase deficiency No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior antineoplastic agent for GBM No concurrent chemotherapy during and for 2 weeks after study No other concurrent antineoplastic investigational agent Endocrine therapy: Prior and concurrent corticosteroids allowed Radiotherapy: No prior radiotherapy to the brain Surgery: See Disease Characteristics Other: Concurrent anticonvulsants allowed Other concurrent cancer therapy allowed if medically necessary

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022256

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Josh Yamada, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00022256     History of Changes
Other Study ID Numbers: MSKCC-01051, CDR0000068799, PCI-PCYC-0206, NCI-G01-1999
Study First Received: August 10, 2001
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Glioblastoma
Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Motexafin gadolinium
Antineoplastic Agents
Contrast Media
Dermatologic Agents
Diagnostic Uses of Chemicals
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014