Sarcoma, KaposiPhase 3NCT00002445
Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients
A Phase 3 study testing IM862 in people with Sarcoma, Kaposi and HIV Infections, run by Cytran at 42 sites in 4 countries.
Trial summary
The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients. 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?
- IM862
- How many people
- 200 participants
- Where
- 42 sitesin 4 countries
- 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
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have AIDS-related Kaposi's sarcoma.
- Have at least 5 skin or mouth sores that do not require chemotherapy.
- Have been taking anti-HIV drugs for at least 8 weeks before study entry with no changes in the regimen.
- Are at least 18 years old.
- Agree to practice effective methods of birth control.
Who cannot join
- Patients will not be eligible for this study if they:
- Have an AIDS-related opportunistic infection (except for genital herpes) within 2 weeks of study entry.
- Have had another type of cancer within the past 2 years (except for certain types of skin cancer, cervical cancer, or anal cancer).
- Have a severe chest cold.
- Have certain other serious medical conditions.
- Have received certain medications, including chemotherapy, within the past 4 weeks.
- Abuse alcohol or drugs.
- Are pregnant or breast-feeding.
Trial locations and contacts
42 sites in 4 countries.
42 sites in 4 countries
United States31 sites
Grady Mem Hosp
Atlanta, Georgia, 30308
Johns Hopkins Oncology
Baltimore, Maryland, 21231
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
Boston Med Ctr
Boston, Massachusetts, 02118
Beth Israel Med Ctr
Boston, Massachusetts, 02215
Northwestern Univ
Chicago, Illinois, 60611
Case Western Reserve Univ
Cleveland, Ohio, 44106
Ohio State Univ
Columbus, Ohio, 43210
Infectious Disease of Indiana
Indianapolis, Indiana, 46218
Cytran Inc
Kirkland, Washington, 98033
AIDS Healthcare Foundation
Los Angeles, California, 90027
LAGLC
Los Angeles, California, 90028
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
Tower ID Med Associates
Los Angeles, California, 90048
UCLA Care Ctr
Los Angeles, California, 90095
Univ of Miami School of Medicine
Miami, Florida, 331361013
Vanderbilt Cancer Ctr
Nashville, Tennessee, 37232
St Vincents Hosp / Clinical Research Program
New York, New York, 10011
New York Univ Med Ctr
New York, New York, 10016
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
Columbia-Presbyterian Hosp
New York, New York, 10032
UMDNJ - New Jersey Med School
Newark, New Jersey, 071032757
BioQuan Research Group
North Miami, Florida, 33161
Pennsylvania Oncology and Hematology Associates
Philadelphia, Pennsylvania, 19106
UCSD Med Ctr
San Diego, California, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Conant Med Ctr
San Francisco, California, 94117
Virginia Mason Med Ctr
Seattle, Washington, 98101
Univ of Washington / Harborview Med Ctr
Seattle, Washington, 98104
Washington Univ School of Medicine
St Louis, Missouri, 63110
Albert Einstein Comprehensive Ctr
The Bronx, New York, 10461
Canada5 sites
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec
Ottawa General Hospital
Ottawa, Ontario
Sunnybrook Health Science Centre
Toronto, Ontario
Toronto Gen Hosp
Toronto, Ontario
BC Cancer Agency
Vancouver, British Columbia
Australia4 sites
St Vincent's Hosp / Dept of Haematology
Darlinghurst
Alfred Hosp
Prahan
Prince of Wales Hosp
Randwick
Taylors Square Clinic
Sydney
About this study
Official title: A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma
The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients.
Read the detailed description
Patients are stratified by CD4 count, viral load, and prior systemic chemotherapy. Patients are randomized equally to receive either IM862 or placebo given intranasally every other day. Patients are seen every 4 weeks for 6 months or until disease progression to evaluate toxicity and efficacy. Quality of life is assessed before treatment, then every month for 6 months. At the end of the 6-month study evaluation period, patients with PR/CR (responders) remain on study and continue blinded treatment for an additional 6 months. For patients with stable disease (non-responders), the treatment assignment is unblinded and off-study IM862 compassionate use is offered for 6 months, regardless of treatment group. For patients with documented progressive disease (treatment failure), the treatment assignment is unblinded and off-study IM862 is offered for 6 months to any patient in the placebo group. For treatment failures in the IM862 group, IM862 is stopped and the patient is allowed other therapy options.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- IM862
- Keywords
- AIDS-Related Opportunistic Infections, Placebos, Sarcoma, Kaposi, Antineoplastic Agents, Treatment Outcome, Quality of Life
- Medical subject headings
- Sarcoma, Kaposi, HIV Infections, AIDS-Related Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM862Drug
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.
- 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
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Cytran
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Parkash Gill, Study chairDavid Scadden, Study chairAriela Noy, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002445
- Sponsor's protocol ID
- 306A
- Other IDs
- KS-20898-01, AMC-013
- Status last verified
- Jun 2001
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00002445
- Acronym / sponsor ID
- 306A
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Placebos, Sarcoma, Kaposi, Antineoplastic Agents, Treatment Outcome, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- CytranIndustry (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.
The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients.
Detailed description
Patients are stratified by CD4 count, viral load, and prior systemic chemotherapy. Patients are randomized equally to receive either IM862 or placebo given intranasally every other day. Patients are seen every 4 weeks for 6 months or until disease progression to evaluate toxicity and efficacy. Quality of life is assessed before treatment, then every month for 6 months. At the end of the 6-month study evaluation period, patients with PR/CR (responders) remain on study and continue blinded treatment for an additional 6 months. For patients with stable disease (non-responders), the treatment assignment is unblinded and off-study IM862 compassionate use is offered for 6 months, regardless of treatment group. For patients with documented progressive disease (treatment failure), the treatment assignment is unblinded and off-study IM862 is offered for 6 months to any patient in the placebo group. For treatment failures in the IM862 group, IM862 is stopped and the patient is allowed other therapy options.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Have AIDS-related Kaposi's sarcoma.
- Have at least 5 skin or mouth sores that do not require chemotherapy.
- Have been taking anti-HIV drugs for at least 8 weeks before study entry with no changes in the regimen.
- Are at least 18 years old.
Key exclusion criteria (8 listed)
- Have an AIDS-related opportunistic infection (except for genital herpes) within 2 weeks of study entry.
- Have had another type of cancer within the past 2 years (except for certain types of skin cancer, cervical cancer, or anal cancer).
- Have a severe chest cold.
- Have certain other serious medical conditions.
- Have received certain medications, including chemotherapy, within the past 4 weeks.
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 |
|---|---|---|
| IM862 | 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 24 Jun 2005.
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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.
Parkash Gill study chair
David Scadden study chair
Ariela Noy study chair
42 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IM862 in people with Sarcoma, Kaposi and HIV Infections, run by Cytran at 42 sites in 4 countries.
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 7 inclusion and 8 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 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 42 sites in United States, Canada, Australia, Belgium. 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?
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?
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.