LymphomaPhase 2NCT00003262
Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
A Phase 2 study testing bleomycin sulfate, filgrastim and Stanford V regimen in people with Lymphoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- bleomycin sulfate, filgrastim and Stanford V regimen
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- May 1997to not given
- 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
DISEASE CHARACTERISTICS:
- Histologically proven Hodgkin's disease:
- Clinical or pathologic stage II - IV
- Stage I with bulky disease (tumor size greater than 10 cm) and B symptoms
- Confirmed HIV infection
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-4
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No severe cardiac disease
Pulmonary:
- No severe pulmonary disease
Other:
- No severe neurologic or metabolic disease
- No concurrent or prior second malignancy except:
- Nonmelanomatous skin cancer
- In situ cancer of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior therapy for Hodgkin's disease
- Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: "Stanford V Regimen" For "Low Risk" Patients, "EBVP Regimen" For "High Risk" Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV infection.
Read the detailed description
OBJECTIVES:
- Investigate the effects on survival, life expectancy and quality, toxicity, and immunological status in low risk patients with Hodgkin's Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin, bleomycin, vinblastine, and prednisone.
OUTLINE: Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status (0-2 vs 3-4), presence or absence of AIDS before the diagnosis of Hodgkin's Disease, and immune status (CD4+ cell count greater vs no greater than 100/mm^3).
- Low risk patients (those with no risk factors) receive the EBVP regimen, as follows:
- Epirubicin intravenously on day 1
- Bleomycin intramuscularly or intravenously on day 1
- Vinblastine intravenously on day 1
- Prednisone orally on days 1-5
- Patients also receive daily injections of filgrastim (granulocyte colony-stimulating factor; G-CSF) on days 6-15. This schedule is repeated every 3 weeks for 6 courses.
- High risk patients (those with one or more risk factors) receive the Stanford V regimen, as follows:
- Doxorubicin and vinblastine intravenously on days 1 and 15
- Mechlorethamine intravenously on day 1
- Vincristine and bleomycin intravenously on days 8 and 22
- Etoposide intravenously on days 15 and 16
- Prednisone orally daily
- Patients also receive daily injections of G-CSF on days 3-7, 9-13, 17-21, and 23-26. This schedule is repeated every 28 days for 3 courses.
Patients are followed every 2 months the first year and then every 3 months thereafter.
PROJECTED ACCRUAL: 20-30 patients will initially be accrued in this study.
- Conditions
- Lymphoma
- Being tested
- bleomycin sulfate, filgrastim, Stanford V regimen, doxorubicin hydrochloride, epirubicin hydrochloride
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, AIDS-related peripheral/systemic lymphoma, HIV-associated Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
filgrastimBiological
Stanford V regimenDrug
epirubicin hydrochlorideDrug
etoposideDrug
mechlorethamine hydrochlorideDrug
prednisoneDrug
vinblastine sulfateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2003 (estimated)
- Study startMay 1997
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 LymphomaStudies 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 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Investigators
- Umberto Tirelli, MD, Study chair, Centro di Riferimento Oncologico - Aviano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003262
- Sponsor's protocol ID
- CDR0000066154
- Other IDs
- ITA-GICAT-POS5, EU-97022
- Status last verified
- Oct 2002
- First submitted
- 1 Nov 1999
- Last updated
- 20 Sep 2013
- Results posted
- No
Publications
Spina M, Gabarre J, Rossi G, Fasan M, Schiantarelli C, Nigra E, Mena M, Antinori A, Ammassari A, Talamini R, Vaccher E, di Gennaro G, Tirelli U. Stanford V regimen and concomitant HAART in 59 patients with Hodgkin disease and HIV infection. Blood. 2002 Sep 15;100(6):1984-8. doi: 10.1182/blood-2002-03-0989.
PubMed 12200356
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: "Stanford V Regimen" For "Low Risk" Patients, "EBVP Regimen" For "High Risk" Patients
- ClinicalTrials.gov ID
- NCT00003262
- Acronym / sponsor ID
- CDR0000066154
- Conditions
- Lymphoma
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, AIDS-related peripheral/systemic lymphoma, HIV-associated Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- May 1997
- First posted
- 23 Apr 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV infection.
Detailed description
OBJECTIVES:
- Investigate the effects on survival, life expectancy and quality, toxicity, and immunological status in low risk patients with Hodgkin's Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin, bleomycin, vinblastine, and prednisone.
OUTLINE: Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status (0-2 vs 3-4), presence or absence of AIDS before the diagnosis of Hodgkin's Disease, and immune status (CD4+ cell count greater vs no greater than 100/mm^3).
- Low risk patients (those with no risk factors) receive the EBVP regimen, as follows:
- Epirubicin intravenously on day 1
- Bleomycin intramuscularly or intravenously on day 1
- Vinblastine intravenously on day 1
- Prednisone orally on days 1-5
- Patients also receive daily injections of filgrastim (granulocyte colony-stimulating factor; G-CSF) on days 6-15. This schedule is repeated every 3 weeks for 6 courses.
- High risk patients (those with one or more risk factors) receive the Stanford V regimen, as follows:
- Doxorubicin and vinblastine intravenously on days 1 and 15
- Mechlorethamine intravenously on day 1
- Vincristine and bleomycin intravenously on days 8 and 22
- Etoposide intravenously on days 15 and 16
- Prednisone orally daily
- Patients also receive daily injections of G-CSF on days 3-7, 9-13, 17-21, and 23-26. This schedule is repeated every 28 days for 3 courses.
Patients are followed every 2 months the first year and then every 3 months thereafter.
PROJECTED ACCRUAL: 20-30 patients will initially be accrued in this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bleomycin sulfate | Biological | – |
| filgrastim | Biological | – |
| Stanford V regimen | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| epirubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| mechlorethamine hydrochloride | Drug | – |
| prednisone | Drug | – |
| vinblastine sulfate | Drug | – |
| vincristine sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Background: PubMed 12200356Spina M, Gabarre J, Rossi G, Fasan M, Schiantarelli C, Nigra E, Mena M, Antinori A, Ammassari A, Talamini R, Vaccher E, di Gennaro G, Tirelli U. Stanford V regimen and concomitant HAART in 59 patients with Hodgkin disease and HIV infection. Blood. 2002 Sep 15;100(6):1984-8. doi: 10.1182/blood-2002-03-0989.
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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.
Umberto Tirelli, MD study chair
Centro di Riferimento Oncologico - Aviano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bleomycin sulfate, filgrastim and Stanford V regimen in people with Lymphoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
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 NCT00003262, 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 20 Sep 2013.