Brain/Spinal Cord Cancers
| Status | Conditions | Phase | Study ID |
| Closed | Adult Anaplastic Astrocytoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Mixed Glioma Recurrent Adult Brain Tumor |
Phase I/II |
7140 NCT01148966 |
RATIONALE: Aminolevulinic acid becomes active when it is exposed to a certain kind of light and may help doctors find and remove tumor cells during surgery.
PURPOSE: This phase I/II trial is studying the side effects and best dose of aminolevulinic acid during surgery in treating patients with malignant brain tumors.
|
|
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion
- Patients may have clinically documented primary malignant glioma for which re-resection is clinically indicated; in this instance, previous pathology slides will be reviewed by UWMC Neuropathology prior to surgery; alternatively, patients may have imaging studies (MRI and /or CT scans), which are highly indicative of a new malignant glioma, for which surgical resection is clinically warranted
- Prior therapy is not a consideration in protocol entry; patients with recurrence of known malignant gliomas are eligible following UWMC neuropathology slide review
- ECOG performance status =< 2 (Karnofsky >= 60%)
- Life expectancy is not a consideration for protocol entry
- Patients must have normal organ and marrow function as defined below:
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) =< 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits OR Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- The effects of ALA on the developing human fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent
- The anticipated histology at resection should include: Glioblastoma, Gliosarcoma, Anaplastic astrocytoma, Anaplastic oligodendroglioma, Anaplastic oligoastrocytoma (mixed glioma); prior therapy is not a consideration in protocol entry
Exclusion
- Prior therapy is not an exclusion criterion
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ALA
- Personal or family history of porphyrias
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because ALA is of unknown teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ALA, breastfeeding should be discontinued if the mother is treated with ALA
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Please remember:
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.
Join Us On