Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain
This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00032097
First received: March 8, 2002
Last updated: February 6, 2009
Last verified: January 2004
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients with glioblastoma multiforme who are undergoing radiation therapy to the brain.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: motexafin gadolinium Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | April 2002 |
OBJECTIVES:
- Determine the toxicity of 2 different schedules of motexafin gadolinium as a radiosensitizer in patients with glioblastoma multiforme receiving cranial radiotherapy.
- Determine the maximum tolerated doses of this drug on these 2 schedules in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the biodistribution of this drug in both neoplastic tissue and normal brain parenchyma in these patients.
- Determine the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue in these patients.
- Correlate the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue with the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120). Patients are sequentially assigned to 1 of 2 treatment groups.
- Group I: Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6 weeks. Patients concurrently undergo cranial radiotherapy once daily 5 days a week for 6 weeks.
- Group II: Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently during radiotherapy. Patients undergo cranial radiotherapy as in group I.
Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 18-30 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 supratentorial grade IV astrocytoma
- Glioblastoma multiforme
- Previously untreated disease
- Measurable and contrast-enhancing tumor by MRI after incomplete resection/biopsy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 4 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 4 times ULN
- PT/APTT normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No uncontrolled hypertension
Other:
- Mini mental state exam score at least 15
- No history of glucose-6-phosphate dehydrogenase deficiency or porphyria
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast
- No serious infection
- No other medical illness that would preclude study participation
- No allergy to MRI contrast (e.g., motexafin gadolinium)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No prior biologic therapy or immunotherapy for this disease, including any of the following:
- Immunotoxins
- Immunoconjugates
- Antisense therapy
- Peptide receptor antagonists
- Interferons
- Interleukins
- Tumor-infiltrating lymphocytes
- Lymphokine-activated killer cell therapy
- Gene therapy
Chemotherapy:
- No prior chemotherapy for this disease
Endocrine therapy:
- Must be on a stable corticosteroid regimen (i.e., no increase within 5 days prior to treatment on this protocol)
- No other prior hormonal therapy for this disease
Radiotherapy:
- No prior radiotherapy for this disease
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- No other concurrent investigational agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032097
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
Sponsors and Collaborators
Investigators
| Study Chair: | James L. Pearlman, MD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00032097 History of Changes |
| Other Study ID Numbers: | CDR0000069257, NABTT-2116, JHOC-NABTT-2116 |
| Study First Received: | March 8, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Motexafin gadolinium Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013