Sarcoma, KaposiPhase 2NCT00001059
Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
A Phase 2 study testing Doxorubicin hydrochloride (liposomal), Filgrastim and Bleomycin sulfate in people with Sarcoma, Kaposi and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.
Trial summary
To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. 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), Filgrastim and Bleomycin sulfate
- How many people
- 120 participants
- Where
- 17 sitesUnited States
- Study dates
- Start not givento Aug 1998
- 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:
- G-CSF.
- Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ).
- PCP prophylaxis (required if CD4 count < 200 cells/mm3).
- Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex.
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- Up to 14 days of metronidazole.
- Recombinant erythropoietin.
- Patients must have:
- Documented HIV infection.
- Advanced stage Kaposi's sarcoma.
- No active acute opportunistic infection.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Significant pulmonary insufficiency (unless due to pulmonary KS).
- Significant cardiac insufficiency.
- Other active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer.
- Grade 2 or worse peripheral neuropathy.
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- Altered mental status that prevents informed consent.
- Active Mycobacterium tuberculosis.
- Hypersensitivity or allergic reaction to any study drugs or E. coli-derived medications such as filgrastim (G-CSF).
- Concurrent Medication:
- Excluded:
- GM-CSF.
- Drugs associated with peripheral neuropathy (other than approved antiretrovirals and vincristine).
- Multi-drug therapy for active Mycobacterium tuberculosis (although isoniazid and pyridoxine is allowed as treatment for a positive PPD, with permission of study chair).
- Concurrent Treatment:
- Excluded:
- Radiation therapy to study marker lesions.
- Patients with the following prior condition are excluded:
- Neuropsychiatric history.
- Prior Medication:
- Excluded:
- Any anti-KS therapy within 21 days prior to study entry.
- Prior systemic therapy with any anthracycline (including liposomal anthracyclines), vincristine, or bleomycin.
- Any investigational drug (other than those available through Treatment IND and used for FDA-sanctioned purposes) within 14 days prior to study entry.
- PER AMENDMENT 11/29/95:
- No more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80262
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
Bmc Actg Crs
Boston, Massachusetts, 02118
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Northwestern University CRS
Chicago, Illinois, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Queens Med. Ctr.
Honolulu, Hawaii, 96813
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
USC CRS
Los Angeles, California, 90033
UCLA CARE Center CRS
Los Angeles, California, 90095
Univ. of Miami AIDS CRS
Miami, Florida, 33136
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021
Ucsf Aids Crs
San Francisco, California
Washington U CRS
St Louis, Missouri, 63110
About this study
Official title: Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma
To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life.
Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
Read the detailed description
Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
Patients are randomized to receive intravenous DOX-SL alone or in combination with vincristine/bleomycin every 2 weeks. Filgrastim ( granulocyte colony-stimulating factor; G-CSF ) may be given as needed for neutropenia.
AS PER AMENDMENT 11/7/96: Based on interim review data, it is recommended that subjects receiving DOX-SL plus vincristine/bleomycin have vincristine/bleomycin discontinued and receive DOX-SL alone unless, in the opinion of the treating physician, they are benefitting from the DOX-SL plus vincristine/bleomycin regimen.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Doxorubicin hydrochloride (liposomal), Filgrastim, Bleomycin sulfate, Vincristine sulfate
- Keywords
- Vincristine, Sarcoma, Kaposi, Liposomes, Doxorubicin, Drug Therapy, Combination, Granulocyte Colony-Stimulating Factor, 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
FilgrastimDrug
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)
- Study completionAug 1998
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.
- 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
- Enrolment
- 120 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Sequus Pharmaceuticals, Amgen
- Responsible party
- Sponsor
- Investigators
- Mitsuyasu R, Study chairKrown S, Study chairVon Roenn JH, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001059
- Sponsor's protocol ID
- ACTG 286
- Other IDs
- 11262
- Status last verified
- Apr 2012
- First submitted
- 2 Nov 1999
- Last updated
- 17 Apr 2012
- Results posted
- No
Publications
Mitsuyasu R, et al. Comparison study of liposomal doxorubicin (DOX) alone or with bleomycin and vincristine (DBV) for treatment of advanced AIDS-associated Kaposi's sarcoma (AIDS-KS): AIDS Clinical Trial Group (ACTG) protocol 286 (meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1997;16:A191
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00001059
- Acronym / sponsor ID
- ACTG 286
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Vincristine, Sarcoma, Kaposi, Liposomes, Doxorubicin, Drug Therapy, Combination, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Bleomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Sequus Pharmaceuticals, Amgen
- Study completion
- Aug 1998 (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 evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life.
Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
Detailed description
Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
Patients are randomized to receive intravenous DOX-SL alone or in combination with vincristine/bleomycin every 2 weeks. Filgrastim ( granulocyte colony-stimulating factor; G-CSF ) may be given as needed for neutropenia.
AS PER AMENDMENT 11/7/96: Based on interim review data, it is recommended that subjects receiving DOX-SL plus vincristine/bleomycin have vincristine/bleomycin discontinued and receive DOX-SL alone unless, in the opinion of the treating physician, they are benefitting from the DOX-SL plus vincristine/bleomycin regimen.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- G-CSF.
- Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ).
- PCP prophylaxis (required if CD4 count < 200 cells/mm3).
- Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex.
- Up to 14 days of metronidazole.
Key exclusion criteria (26 listed)
- Significant pulmonary insufficiency (unless due to pulmonary KS).
- Significant cardiac insufficiency.
- Other active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer.
- Grade 2 or worse peripheral neuropathy.
- Altered mental status that prevents informed consent.
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 | – |
| Filgrastim | Drug | – |
| Bleomycin sulfate | Drug | – |
| Vincristine sulfate | 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 17 Apr 2012.
- BackgroundMitsuyasu R, et al. Comparison study of liposomal doxorubicin (DOX) alone or with bleomycin and vincristine (DBV) for treatment of advanced AIDS-associated Kaposi's sarcoma (AIDS-KS): AIDS Clinical Trial Group (ACTG) protocol 286 (meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1997;16:A191
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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.
Mitsuyasu R study chair
Krown S study chair
Von Roenn JH study chair
17 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 (liposomal), Filgrastim and Bleomycin sulfate in people with Sarcoma, Kaposi and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 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 12 inclusion and 26 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 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 NCT00001059, 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 17 Apr 2012.