Sarcoma, KaposiPhase 3NCT00002318
A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
A Phase 3 study testing Doxorubicin hydrochloride (liposomal), Bleomycin sulfate and Vincristine sulfate in people with Sarcoma, Kaposi and HIV Infections, run by Sequus Pharmaceuticals at 28 sites in United States.
Trial summary
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Kaposi, HIV Infections
- What is being tested?
- Doxorubicin hydrochloride (liposomal), Bleomycin sulfate and Vincristine sulfate
- How many people
- 225 participants
- Where
- 28 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
- Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
- Foscarnet for new episodes of cytomegalovirus infection.
- Colony-stimulating factors and erythropoietin.
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- Patients must have:
- Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
- At least 25 mucocutaneous lesions.
- Ten or more new lesions in the prior month.
- Documented visceral disease with at least two accessible cutaneous lesions.
- Two accessible cutaneous lesions with edema.
- Documented anti-HIV antibody.
- No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
- Life expectancy > 4 months.
- NOTE:
- Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, are eligible to enter the Liposome Technology open trial using DOX-SL alone.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Clinically significant cardiac, hepatic, or renal disease.
- Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss.
- Inability to comply with the study.
- Concurrent Medication:
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- Excluded:
- Other cytotoxic chemotherapy.
- Ganciclovir.
- Patients with the following prior conditions are excluded:
- Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
- History of idiosyncratic or allergic reaction to bleomycin or vincristine.
- Prior Medication:
- Excluded:
- Prior anthracycline therapy.
- Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.
- Prior Treatment:
- Excluded:
- Radiation or electron beam therapy within the past 3 weeks.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
American Med Research Institute
Atlanta, Georgia, 30329
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, 30345
East Bay AIDS Ctr
Berkeley, California, 94705
Pacific Oaks Med Group
Beverly Hills, California, 90211
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwestern Med Faculty Foundation
Chicago, Illinois, 60611
Rush Presbyterian Med College
Chicago, Illinois, 60612
Illinois Masonic Med Ctr / The Cancer Ctr
Chicago, Illinois, 60657
Comprehensive Care Ctr
Dallas, Texas, 75235
Henry Ford Hosp
Detroit, Michigan, 48202
Hematology - Oncology Med Group of San Fernando Valley
Encino, California, 91436
Baylor College of Medicine
Houston, Texas, 77030
Dr Becky Miller
Los Angeles, California, 90048
Univ of Miami School of Medicine
Miami, Florida, 33136
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011
New York Univ Med Ctr
New York, New York, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10023
Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia, Pennsylvania, 19146
Apogee Med Group
San Diego, California, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Kaiser Permanente Med Ctr
San Francisco, California, 94115
UCSF
San Francisco, California, 94117
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
UCSF
San Francisco, California, 941430324
Pacific Oaks Med Group
Sherman Oaks, California, 91403
Washington Univ
St Louis, Missouri, 63108
H Lee Moffit Cancer Ctr and Research Institute
Tampa, Florida, 33612
Dr Mahmoud Mustafa
Washington D.C., District of Columbia, 20037
About this study
Official title: Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.
Read the detailed description
Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients must agree to have one or more representative KS lesions biopsied.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Doxorubicin hydrochloride (liposomal), Bleomycin sulfate, Vincristine sulfate, Doxorubicin hydrochloride
- Keywords
- Vincristine, Sarcoma, Kaposi, Liposomes, Doxorubicin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Bleomycin, Drug Carriers
- Medical subject headings
- Sarcoma, Kaposi, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxorubicin hydrochloride (liposomal)Drug
Bleomycin sulfateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, KaposiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 225 participants
Sponsor and investigators
- Lead sponsor
- Sequus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002318
- Sponsor's protocol ID
- 134A
- Other IDs
- LTI-30-10
- Status last verified
- Jan 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. doi: 10.1200/JCO.1996.14.8.2353.
PubMed 8708728
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00002318
- Acronym / sponsor ID
- 134A
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Vincristine, Sarcoma, Kaposi, Liposomes, Doxorubicin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Bleomycin, Drug Carriers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants
- Lead sponsor
- Sequus PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.
Detailed description
Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients must agree to have one or more representative KS lesions biopsied.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
- Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
- Foscarnet for new episodes of cytomegalovirus infection.
- Colony-stimulating factors and erythropoietin.
- Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
Key exclusion criteria (19 listed)
- Clinically significant cardiac, hepatic, or renal disease.
- Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss.
- Inability to comply with the study.
- Other cytotoxic chemotherapy.
- Ganciclovir.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxorubicin hydrochloride (liposomal) | Drug | – |
| Bleomycin sulfate | Drug | – |
| Vincristine sulfate | Drug | – |
| Doxorubicin hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 8708728Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. doi: 10.1200/JCO.1996.14.8.2353.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxorubicin hydrochloride (liposomal), Bleomycin sulfate and Vincristine sulfate in people with Sarcoma, Kaposi and HIV Infections, run by Sequus Pharmaceuticals at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.