HIV InfectionsPhase 2NCT00000626
Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
A Phase 2 study testing Vinblastine sulfate, Dacarbazine and Filgrastim in people with HIV Infections and Hodgkin's Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections, Hodgkin's Disease
- What is being tested?
- Vinblastine sulfate, Dacarbazine and Filgrastim
- How many people
- 27 participants
- Where
- 8 sitesUnited States
- Study dates
- Start not givento Feb 1999
- 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:
- Required:
- PCP prophylaxis consisting of Bactrim, aerosolized pentamidine, or dapsone.
- Recommended:
- Antiemetic therapy within 30 minutes of chemotherapy.
- Allowed:
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- Antiretroviral medication after two cycles of chemotherapy, provided the patient has not experienced grade 3 neutropenia while on chemotherapy or on previous antiretroviral therapy.
- Acetaminophen and/or nonsteroidal anti-inflammatory agents.
- Bone marrow-suppressive agents, such as ganciclovir, Fansidar, Bactrim, and dapsone.
- Maintenance therapy for chronic opportunistic infection.
- Concurrent Treatment:
- Allowed:
- Cranial irradiation (2400 rads) for patients with CNS involvement.
- Patients must have:
- Documented HIV infection or diagnosis of AIDS.
- Hodgkin's disease.
- Consent of parent or guardian and have care directly supervised by a pediatric oncologist if under 18 years of age.
- Prior Medication:
- Allowed:
- Maintenance therapy for opportunistic infections.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Second primary cancer other than Kaposi's sarcoma that does not require systemic therapy, nonmelanomatous skin cancer, Bowen's disease, or carcinoma in situ of the cervix.
- Acute, active bacterial or opportunistic infection requiring ongoing therapy if such therapy has been initiated within the past 2 weeks.
- Known hypersensitivity (e.g., anaphylactoid reaction, bronchospasm) to E. coli-derived proteins.
- Prior Medication:
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- Excluded:
- Prior chemotherapy for Hodgkin's disease.
- Antiretroviral therapy within 2 weeks prior to study entry.
- Prior Treatment:
- Excluded:
- Prior radiotherapy for Hodgkin's disease.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York
Northwestern University CRS
Chicago, Illinois, 60611
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 432101228
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250
USC CRS
Los Angeles, California, 900331079
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
Washington U CRS
St Louis, Missouri
About this study
Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease.
Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen.
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
Read the detailed description
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkin's disease. ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) is administered on days 1 and 15 of each cycle, and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle. All patients receive four cycles of treatment and are then restaged. Patients with a complete response (CR) following the initial four cycles receive two additional cycles of ABVD / G-CSF. Patients with a partial response following the initial four cycles receive two additional cycles of ABVD / G-CSF and are again restaged; those who have achieved a CR at that point then receive two more cycles, while those without CR discontinue study therapy. Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study. Concomitant PCP prophylaxis is administered.
- Conditions
- HIV Infections, Hodgkin's Disease
- Being tested
- Vinblastine sulfate, Dacarbazine, Filgrastim, Bleomycin sulfate, Doxorubicin hydrochloride
- Keywords
- Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, AIDS-Related Complex, Hodgkin Disease, ABVD protocol
- Medical subject headings
- HIV Infections, Hodgkin Disease, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinblastine sulfateDrug
DacarbazineDrug
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 completionFeb 1999
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 HIV InfectionsStudies 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
- 27 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Levine A, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000626
- Sponsor's protocol ID
- ACTG 149
- Other IDs
- 11124
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 27 Oct 2021
- Results posted
- No
Publications
Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50. doi: 10.1097/00126334-200008150-00009.
PubMed 11035615Levine AM, et al. Prospective, multicenter phase II trial of ABVD chemotherapy with G-CSF in HIV-infected patients with Hodgkin's disease (HD): AIDS Clincial Trials Group (ACTG) Study 149. Proc Annu Meet Am Soc Clin Oncol. 1997;16:A194
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00000626
- Acronym / sponsor ID
- ACTG 149
- Conditions
- HIV Infections, Hodgkin's Disease
- Keywords
- Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, AIDS-Related Complex, Hodgkin Disease, ABVD protocol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Amgen
- Study completion
- Feb 1999 (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 assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease.
Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen.
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
Detailed description
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkin's disease. ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) is administered on days 1 and 15 of each cycle, and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle. All patients receive four cycles of treatment and are then restaged. Patients with a complete response (CR) following the initial four cycles receive two additional cycles of ABVD / G-CSF. Patients with a partial response following the initial four cycles receive two additional cycles of ABVD / G-CSF and are again restaged; those who have achieved a CR at that point then receive two more cycles, while those without CR discontinue study therapy. Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study. Concomitant PCP prophylaxis is administered.
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 (20 listed)
- PCP prophylaxis consisting of Bactrim, aerosolized pentamidine, or dapsone.
- Antiemetic therapy within 30 minutes of chemotherapy.
- Antiretroviral medication after two cycles of chemotherapy, provided the patient has not experienced grade 3 neutropenia while on chemotherapy or on previous antiretroviral therapy.
- Acetaminophen and/or nonsteroidal anti-inflammatory agents.
- Bone marrow-suppressive agents, such as ganciclovir, Fansidar, Bactrim, and dapsone.
Key exclusion criteria (12 listed)
- Second primary cancer other than Kaposi's sarcoma that does not require systemic therapy, nonmelanomatous skin cancer, Bowen's disease, or carcinoma in situ of the cervix.
- Acute, active bacterial or opportunistic infection requiring ongoing therapy if such therapy has been initiated within the past 2 weeks.
- Known hypersensitivity (e.g., anaphylactoid reaction, bronchospasm) to E. coli-derived proteins.
- Prior chemotherapy for Hodgkin's disease.
- Antiretroviral therapy within 2 weeks prior to study entry.
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 |
|---|---|---|
| Vinblastine sulfate | Drug | – |
| Dacarbazine | Drug | – |
| Filgrastim | Drug | – |
| Bleomycin sulfate | Drug | – |
| 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 27 Oct 2021.
- Background: PubMed 11035615Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50. doi: 10.1097/00126334-200008150-00009.
- BackgroundLevine AM, et al. Prospective, multicenter phase II trial of ABVD chemotherapy with G-CSF in HIV-infected patients with Hodgkin's disease (HD): AIDS Clincial Trials Group (ACTG) Study 149. Proc Annu Meet Am Soc Clin Oncol. 1997;16:A194
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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.
Levine A study chair
8 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 Vinblastine sulfate, Dacarbazine and Filgrastim in people with HIV Infections and Hodgkin's Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 20 inclusion and 12 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 NCT00000626, 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 27 Oct 2021.