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Anti-tumor antibiotic
DOX-SL vs. Chemotherapy for Kaposi Sarcoma
Phase 3
Waitlist Available
Research Sponsored by Sequus Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma with specific criteria
No active opportunistic infection with specified microorganisms if under treatment with myelotoxic drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for AIDS-related Kaposi's sarcoma, comparing it to an established treatment. They are testing for safety and effectiveness.
Who is the study for?
This trial is for AIDS patients with severe Kaposi's sarcoma. Participants must have HIV antibodies, a life expectancy over 4 months, and no major organ disease or recent chemotherapy. They can receive treatments for certain infections and stable antiretroviral therapy.Check my eligibility
What is being tested?
The study compares DOX-SL (a liposomal doxorubicin) to the ABV combination (Adriamycin/doxorubicin, bleomycin, vincristine) in treating severe AIDS-related Kaposi's sarcoma to see which is more effective and better tolerated.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of drugs, heart or liver issues due to Adriamycin/doxorubicin use, lung problems from Bleomycin, nerve damage from Vincristine, and general symptoms like fatigue or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Kaposi's sarcoma is worsening and confirmed by biopsy.
Select...
I do not have an active infection while on drugs that can lower my immunity.
Select...
I am taking Foscarnet for a new CMV infection.
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
Find a Location
Who is running the clinical trial?
Sequus PharmaceuticalsLead Sponsor
5 Previous Clinical Trials
560 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently taking any other chemotherapy drugs or Ganciclovir.My Kaposi's sarcoma is worsening and confirmed by biopsy.I haven't had radiation or electron beam therapy in the last 3 weeks.I am on stable doses of medications for PCP, cryptococcal, herpes infections, and HIV.My bone marrow function is permanently damaged due to extensive chemotherapy for a previous cancer.I do not have an active infection while on drugs that can lower my immunity.I haven't had anthracycline, chemotherapy, or interferon treatments in the last 4 weeks.I do not have serious heart, liver, or kidney disease.I am not on treatment for TB, fungal, or herpes infections that affects my bone marrow.I am not currently using medications to boost my blood cell counts.I am taking Foscarnet for a new CMV infection.I experience significant numbness or weakness in my limbs.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has this drug been federally approved for public consumption?
"This trial is a Phase 3, which suggests that while there is some evidence of this treatment's efficacy, there is also extensive data demonstrating its safety. Consequently, our team rates the safety as a 3."
Answered by AI
Are there several locations running this study in the city?
"So far, this study has enrolled patients from 27 locations, which include Apogee Med Group in San Diego, California, UCSF - San Francisco Gen Hosp in San Francisco, Florida, and H Lee Moffit Cancer Ctr and Research Institute in Tampa, Georgia."
Answered by AI
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