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Alkylating agents
Combination Chemotherapy + Hyperthermia for Advanced Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pulmonary: FEV_1 at least 70% of predicted, Arterial PO_2 at least 60 mmHg on room air, No massive (greater than 30% involvement) lung disease, DLCO greater than 50% of predicted
Renal: Creatinine no greater than 1.8 mg/dL, Creatinine clearance at least 45 mL/min, BUN no greater than 25 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the side effects of combining cisplatin, gemcitabine, interferon alfa, and whole-body hyperthermia to see if it is an effective treatment for patients with metastatic, recurrent, or refractory cancer.
Who is the study for?
Adults over 18 with advanced cancer that has spread, come back, or didn't respond to treatment can join. They need normal kidney and liver function, no severe heart or lung disease, no brain metastases or seizures, and a decent performance status. Pregnant women and those with significant emotional issues are excluded.Check my eligibility
What is being tested?
This trial tests how well the combination of chemotherapy drugs Cisplatin and Gemcitabine works with Interferon Alfa and whole-body hyperthermia (heating the body) in patients whose cancer is advanced. It's looking at safety and effectiveness.See study design
What are the potential side effects?
Possible side effects include reactions to heat like dehydration or burns; chemotherapy-related nausea, vomiting, hair loss; interferon alfa may cause flu-like symptoms; all treatments could potentially lower blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function is mostly normal, with no severe lung disease.
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My kidney function tests are within normal limits.
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I am 18 years old or older.
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My liver function tests are within normal limits.
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My cancer has spread, come back, or is not responding to treatment.
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I can care for myself but may not be able to do active work.
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My blood cell counts are within a healthy range and I don't have bleeding disorders.
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
Duration of stable disease
Overall survival
Progression-free survival
+2 moreFind a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
906 Previous Clinical Trials
323,084 Total Patients Enrolled
Joan M.C. Bull, MDStudy ChairThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
82 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function is mostly normal, with no severe lung disease.My kidney function tests are within normal limits.I am 18 years old or older.I do not have brain metastases or CNS disorders.My liver function tests are within normal limits.My cancer has spread, come back, or is not responding to treatment.It has been over 6 days since my major chest or belly surgery.I can care for myself but may not be able to do active work.My blood cell counts are within a healthy range and I don't have bleeding disorders.I am not taking heart medications, blood thinners, steroids, or aspirin.I don't have any other illnesses that would stop me from following treatment.My heart is healthy with no history of major heart issues.
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 condition still enroll in the trial?
"This particular clinical study is not enrolling patients at the moment, as per information on clinicaltrials.gov. The trial was originally posted on 8/1/1999 and last updated on 4/29/2009; however, there are many other trials (151 to be exact) that are currently looking for participants."
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