Sarcoma, KaposiPhase 2NCT00001114
The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients With Kaposi's Sarcoma
A Phase 2 study testing Interferon alfa-2b and Didanosine in people with Sarcoma, Kaposi and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 2 countries.
Trial summary
Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's sarcoma associated with HIV infection. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sarcoma, Kaposi, HIV Infections
- What is being tested?
- Interferon alfa-2b and Didanosine
- How many people
- 90 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Start not givento Mar 2000
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Chemoprophylaxis for candidiasis and herpes simplex.
- Up to 14 days of metronidazole.
- Recombinant erythropoietin.
- G-CSF (for severe cases of neutropenia).
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- Isoniazid for treatment of TB if given in conjunction with pyridoxine.
- Required in patients with CD4 counts < 200 cells/mm3:
- Prophylaxis for PCP.
- PER AMENDMENT 9/19/96:
- After the first 16 weeks of combined IFN alpha-2b and ddI treatment subjects may at the discretion of the investigator receive any FDA approved antiretroviral drug regimen in addition to or in place of ddI.
- Patients must have:
- Positive antibody to HIV.
- Biopsy-proven Kaposi's sarcoma (at least 5 measurable lesions, with at least 1 measurable cutaneous lesion) involving the skin, lymph nodes, oral cavity, or asymptomatic lesions of the GI tract not requiring systemic chemotherapy. Lung involvement with Kaposi's sarcoma excludes.
- Consent of parent or guardian if less than 18 years of age.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Concurrent opportunistic infection or B symptoms including unexplained fever, night sweats, weight loss > 10 percent, and diarrhea lasting more than 2 weeks.
- Visceral (non-nodal) Kaposi's sarcoma requiring cytotoxic chemotherapy.
- Severe (> 2+) tumor-associated edema.
- Concurrent neoplasia other than basal cell carcinoma, or anogenital intraepithelial neoplasia.
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- Current clinical evidence of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not well controlled by anti-seizure medications.
- Significant symptomatic cardiac disease.
- Medical contraindication.
- Concurrent Medication:
- Excluded:
- Other investigational, antiviral, immunomodulating, or antitumor agents.
- Drugs associated with peripheral neuropathy (other than ddI).
- PER AMENDMENT 9/19/96:
- Other antiretroviral agents may not be taken during the first 16 weeks of combined IFN alpha-2b and ddI treatment.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- Opportunistic infection or B symptoms including unexplained fever, night sweats, weight loss > 10 percent, and diarrhea lasting more than 2 weeks.
- Prior grade 3 or 4 toxicity attributed to ddI therapy.
- Prior history of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not well controlled by anti-seizure medications.
- History of myocardial infarction or ventricular arrhythmias.
- Prior Medication:
- Excluded:
- Prior IFN-alpha.
- Corticosteroids, biological response modifiers, cytotoxic chemotherapy, or known neurotoxic drugs (other than ddI or ddC) within 30 days prior to study entry.
- Therapy with antiretroviral drugs (other than ddI) within 7 days prior to study entry.
- Prior Treatment:
- Excluded:
- Radiation therapy within 30 days prior to study entry.
- Risk Behavior:
- Alcohol consumption is strongly discouraged.
- Patients considered to be noncompliant should be excluded.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80262
Bmc Actg Crs
Boston, Massachusetts, 02118
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
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021
Stanford CRS
Palo Alto, California, 94115
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
Washington U CRS
St Louis, Missouri
About this study
Official title: A Randomized Phase II Trial to Determine the Safety, Tolerance, and Efficacy of Two Doses of Interferon Alfa-2b Combined With Didanosine in Patients With Kaposi's Sarcoma
Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's sarcoma associated with HIV infection.
Secondary: To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression and markers of immune function.
Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and suppression of HIV in some patients. Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha.
Read the detailed description
Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and suppression of HIV in some patients. Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha.
Up to 90 patients are randomized to receive either low or high doses of IFN-alpha (1 or 10 million Units/day) in combination with a fixed dose of ddI. Fourteen patients are initially entered at each dose level. If no objective antitumor responses are observed among the first 14 patients at a given dose, no further patients are entered on that treatment arm. If one or more antitumor responses are seen at a given dose, up to 45 patients may be entered on that treatment arm. Patients must complete at least 4 weeks of study therapy to be considered evaluable for tumor response. Treatment is continued until tumor progression or unacceptable toxicity occurs. PER AMENDMENT 9/19/96: NOTE - After 16 weeks of treatment subjects may receive any FDA approved antiretroviral drug regimen in addition to or in place of ddI.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Interferon alfa-2b, Didanosine
- Keywords
- Sarcoma, Kaposi, Didanosine, Drug Interactions, Acquired Immunodeficiency Syndrome, Interferon-alpha
- 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.
Interferon alfa-2bDrug
DidanosineDrug
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 completionMar 2000
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
- 90 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Schering-Plough, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Krown SE, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001114
- Sponsor's protocol ID
- ACTG 206
- Other IDs
- 11183
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Krown SE, Li P, Von Roenn JH, Paredes J, Huang J, Testa MA. Efficacy of low-dose interferon with antiretroviral therapy in Kaposi's sarcoma: a randomized phase II AIDS clinical trials group study. J Interferon Cytokine Res. 2002 Mar;22(3):295-303. doi: 10.1089/107999002753675712.
PubMed 12034036
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial to Determine the Safety, Tolerance, and Efficacy of Two Doses of Interferon Alfa-2b Combined With Didanosine in Patients With Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00001114
- Acronym / sponsor ID
- ACTG 206
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Sarcoma, Kaposi, Didanosine, Drug Interactions, Acquired Immunodeficiency Syndrome, Interferon-alpha
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Schering-Plough, Bristol-Myers Squibb
- Study completion
- Mar 2000 (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.
Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's sarcoma associated with HIV infection.
Secondary: To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression and markers of immune function.
Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and suppression of HIV in some patients. Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha.
Detailed description
Previous studies have shown that IFN-alpha can induce regression of Kaposi's sarcoma and suppression of HIV in some patients. Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha.
Up to 90 patients are randomized to receive either low or high doses of IFN-alpha (1 or 10 million Units/day) in combination with a fixed dose of ddI. Fourteen patients are initially entered at each dose level. If no objective antitumor responses are observed among the first 14 patients at a given dose, no further patients are entered on that treatment arm. If one or more antitumor responses are seen at a given dose, up to 45 patients may be entered on that treatment arm. Patients must complete at least 4 weeks of study therapy to be considered evaluable for tumor response. Treatment is continued until tumor progression or unacceptable toxicity occurs. PER AMENDMENT 9/19/96: NOTE - After 16 weeks of treatment subjects may receive any FDA approved antiretroviral drug regimen in addition to or in place of ddI.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Chemoprophylaxis for candidiasis and herpes simplex.
- Up to 14 days of metronidazole.
- Recombinant erythropoietin.
- G-CSF (for severe cases of neutropenia).
- Isoniazid for treatment of TB if given in conjunction with pyridoxine.
Key exclusion criteria (34 listed)
- Concurrent opportunistic infection or B symptoms including unexplained fever, night sweats, weight loss > 10 percent, and diarrhea lasting more than 2 weeks.
- Visceral (non-nodal) Kaposi's sarcoma requiring cytotoxic chemotherapy.
- Severe (> 2+) tumor-associated edema.
- Concurrent neoplasia other than basal cell carcinoma, or anogenital intraepithelial neoplasia.
- Current clinical evidence of peripheral neuropathy (= or > grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not well controlled by anti-seizure medications.
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 |
|---|---|---|
| Interferon alfa-2b | Drug | – |
| Didanosine | 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 1 Nov 2021.
- Background: PubMed 12034036Krown SE, Li P, Von Roenn JH, Paredes J, Huang J, Testa MA. Efficacy of low-dose interferon with antiretroviral therapy in Kaposi's sarcoma: a randomized phase II AIDS clinical trials group study. J Interferon Cytokine Res. 2002 Mar;22(3):295-303. doi: 10.1089/107999002753675712.
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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.
Krown SE study chair
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon alfa-2b and Didanosine in people with Sarcoma, Kaposi and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 2 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 15 inclusion and 34 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 1 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 13 sites in United States, Puerto Rico. 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 NCT00001114, 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 1 Nov 2021.