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Platinum-based Compound
Combination Therapy for Brain Tumor
Phase 2
Waitlist Available
Led By Edward F. McClay, MD
Research Sponsored by San Diego Pacific Oncology & Hematology Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No acquired immune deficiency syndrome (AIDS)
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying radiation therapy in combination with temozolomide, tamoxifen, and carboplatin to treat patients with malignant gliomas.
Who is the study for?
This trial is for patients with specific brain tumors called malignant gliomas who've had surgery within the last 6 weeks. They should have a life expectancy over 12 weeks, be in good neurological and general health, not pregnant or nursing, and willing to use contraception. Those with major illnesses, prior head/neck radiotherapy, other cancers (except certain skin cancers or cervical carcinoma in situ), AIDS, or certain types of glioma are excluded.Check my eligibility
What is being tested?
The study tests if combining radiation therapy with chemotherapy drugs temozolomide and carboplatin plus tamoxifen (which may make tumor cells more sensitive) can better kill tumor cells in malignant glioma patients compared to current treatments.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation like fatigue and skin irritation; chemotherapy-related nausea, vomiting, hair loss; blood cell count changes leading to increased infection risk; and possible liver function alterations due to medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have AIDS.
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I can take care of myself and am up and about more than half of my waking hours.
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I have been diagnosed with a specific type of brain tumor.
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I can do most daily activities without help.
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My bilirubin levels are not more than three times the upper limit.
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My tumor is located above the cerebellum.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Progression-free survival
Toxicity
+1 moreFind a Location
Who is running the clinical trial?
San Diego Pacific Oncology & Hematology AssociatesLead Sponsor
3 Previous Clinical Trials
304 Total Patients Enrolled
Edward F. McClay, MDPrincipal InvestigatorSan Diego Pacific Oncology & Hematology Associates
3 Previous Clinical Trials
304 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have AIDS.I don't have any major illnesses or mental health issues that would stop me from following the study's requirements.I haven't had any cancer except for cervical or non-melanoma skin cancer in the last 3 years.I do not have any major illnesses or mental health issues that would stop me from following the study's requirements.I had surgery within the last 6 weeks.I can take care of myself and am up and about more than half of my waking hours.I have not had radiation therapy on my head or neck.I have been diagnosed with a specific type of brain tumor.My brain tumor is not a well-differentiated astrocytoma or glioma with oligodendroglial component.My brain cancer is not in multiple places.I am not receiving any other treatments for my tumor.I can do most daily activities without help.My bilirubin levels are not more than three times the upper limit.I haven't had any cancer except for cervical or non-melanoma skin cancer in the last 3 years.I do not have AIDS.I do not have recurrent glioblastoma multiforme.My tumor is located above the cerebellum.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can people with the target condition join this research project at this time?
"According to the information available on clinicaltrials.gov, this particular trial is not currently looking for patients. This trial was first posted on December 1st 2006 and was most recently updated on January 9th 2014. There are 444 other trials that are actively recruiting patients right now."
Answered by AI
What are the risks associated with this treatment option?
"This treatment received a safety score of 2 out of 3 because, while Phase 2 trials provide some evidence that the intervention is safe, there is no data yet supporting whether or not it is effective."
Answered by AI
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