Sarcoma, KaposiPhase 2NCT00000996
A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
A Phase 2 study testing Doxorubicin hydrochloride in people with Sarcoma, Kaposi and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
Trial summary
To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin. Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. 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
- How many people
- 48 participants
- Where
- 12 sitesUnited States
- Study dates
- Start not givento Jun 1990
- Phase
- Phase 2
- 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:
- Ongoing and/or maintenance therapy for opportunistic infection.
- Medications for nausea, vomiting, and diarrhea resulting from drug.
- Patients must have AIDS related Kaposi's sarcoma.
- Patients may demonstrate positive blood cultures for Mycobacterium avium-complex or cytomegalovirus.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions will be excluded:
- Patients with active opportunistic infection.
- Patients with concurrent neoplasm other than squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
- Patients with significant neurologic, cardiac, or liver disease.
- Concurrent Medication:
Show all 25Show fewer
- Excluded:
- Antiretroviral agents.
- Immunomodulators.
- Corticosteroids.
- Experimental drugs.
- The following patients will be excluded from the study:
- Patients with lymphadenopathy alone and/or visceral disease alone secondary to Kaposi's sarcoma.
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapy.
- Excluded within 30 days of study entry:
- Antiretroviral agents.
- Biologic modifiers.
- Corticosteroids.
- Prior Treatment:
- Excluded:
- Total body electron beam therapy.
- Excluded within 30 days of study entry:
- Radiation therapy.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
UCLA CARE Ctr
Los Angeles, California, 90095
Univ of Miami School of Medicine
Miami, Florida, 331361013
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
Univ of Rochester Medical Center
Rochester, New York, 14642
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
About this study
Official title: Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma
To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin.
Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.
Read the detailed description
Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.
Patients are stratified for non-therapy purposes into 2 groups; doxorubicin is given intravenously (IV) every week on an outpatient basis. Patients are monitored carefully, and weekly blood samples are taken to determine the effectiveness and safety of treatment. Patients are evaluated for toxicity after one dose of the drug and weekly thereafter. Patients are evaluated for response to the drug after 4 weeks and monthly thereafter.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Doxorubicin hydrochloride
- Keywords
- Doxorubicin, Drug Evaluation, Acquired Immunodeficiency Syndrome
- 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.
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)
- Study completionJun 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, KaposiStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 48 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- MA Fischl, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000996
- Sponsor's protocol ID
- ACTG 006
- Other IDs
- 10982
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Walker RE, et al. The safety, pharmacokinetics, and antiviral activity of N-acetylcysteine in HIV-infected individuals. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo8 (abstract no MoB 0022)
Fischl MA, Krown SE, O'Boyle KP, Mitsuyasu R, Miles S, Wernz JC, Volberding PA, Kahn J, Groopman JE, Feinberg J, et al. Weekly doxorubicin in the treatment of patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group. J Acquir Immune Defic Syndr (1988). 1993 Mar;6(3):259-64.
PubMed 8450401
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00000996
- Acronym / sponsor ID
- ACTG 006
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Doxorubicin, Drug Evaluation, Acquired Immunodeficiency Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jun 1990 (actual)
- 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 study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin.
Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.
Detailed description
Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.
Patients are stratified for non-therapy purposes into 2 groups; doxorubicin is given intravenously (IV) every week on an outpatient basis. Patients are monitored carefully, and weekly blood samples are taken to determine the effectiveness and safety of treatment. Patients are evaluated for toxicity after one dose of the drug and weekly thereafter. Patients are evaluated for response to the drug after 4 weeks and monthly thereafter.
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 (6 listed)
- Ongoing and/or maintenance therapy for opportunistic infection.
- Medications for nausea, vomiting, and diarrhea resulting from drug.
- Patients must have AIDS related Kaposi's sarcoma.
- Patients may demonstrate positive blood cultures for Mycobacterium avium-complex or cytomegalovirus.
Key exclusion criteria (25 listed)
- Patients with active opportunistic infection.
- Patients with concurrent neoplasm other than squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
- Patients with significant neurologic, cardiac, or liver disease.
- Antiretroviral agents.
- Immunomodulators.
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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- BackgroundWalker RE, et al. The safety, pharmacokinetics, and antiviral activity of N-acetylcysteine in HIV-infected individuals. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo8 (abstract no MoB 0022)
- Background: PubMed 8450401Fischl MA, Krown SE, O'Boyle KP, Mitsuyasu R, Miles S, Wernz JC, Volberding PA, Kahn J, Groopman JE, Feinberg J, et al. Weekly doxorubicin in the treatment of patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group. J Acquir Immune Defic Syndr (1988). 1993 Mar;6(3):259-64.
Related trials for Sarcoma, Kaposi
Recruiting
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
Cervical Cancer, Kaposi Sarcoma
RecruitingObservational study
Natural History Study of Kaposi Sarcoma
Kaposi Sarcoma, HIV
Active, not recruitingPhase 2
Trial of Ixazomib for Kaposi Sarcoma
Kaposi Sarcoma, Skin
Active, not recruitingPhase 1
Pomalidomide in Combination With Liposomal Doxorubicin in People With Advanced or Refractory Kaposi Sarcoma
Kaposi Sarcoma
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
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.
MA Fischl study chair
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxorubicin hydrochloride in people with Sarcoma, Kaposi and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 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 6 inclusion and 25 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: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT00000996, which also lists 2 linked publications.
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 4 Nov 2021.