LymphomaPhase 2NCT00003575
Interleukin-12 Following Chemotherapy in Treating Patients With Refractory HIV-Associated Non-Hodgkin's Lymphoma
A Phase 2 study testing filgrastim, recombinant interleukin-12 and etoposide in people with Lymphoma, run by National Cancer Institute (NCI) at 10 sites in United States.
Trial summary
Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in treating patients who have refractory HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim, recombinant interleukin-12 and etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 1999to Apr 2002
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- HIV-infected patients with histologically or cytologically proven intermediate grade large cell lymphoma; high grade large cell immunoblastic lymphoma; or high grade small noncleaved cell lymphoma who have either failed to respond to or relapsed following first line combination chemotherapy
- Bidimensionally measurable disease
- No CNS lymphoma (parenchymal brain or spinal cord tumor)
- No meningeal lymphoma
- A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
- Age: 18 to 70
- Performance status: Karnofsky 60-100%
- Absolute neutrophil count at least 1,000/mm3
- Platelet count greater than 75,000/mm3
- Hematologic criteria not applicable if abnormal functions are attributable to lymphomatous infiltration of bone marrow or liver
- Bilirubin less than 2.0 mg/dL, except in patients receiving indinavir who have isolated hyperbilirubinemia
- Transaminases less than 5 times upper limit of normal
- Hepatic criteria not applicable if abnormal functions are attributable to lymphomatous infiltration of bone marrow or liver
- Creatinine clearance greater than 60 mL/min
- No other prior or concurrent malignancy except carcinoma in situ of the cervix or nonmetastatic nonmelanomatous skin cancer
- No acute active opportunistic infection requiring antibiotic treatment Patients with Mycobacterium avium complex allowed
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior immunomodulating agents
- Concurrent filgrastim (G-CSF) allowed
- Concurrent epoetin alfa allowed
- Concurrent antibiotics may be given if clinically indicated during study
- No more than 2 prior standard treatment regimens for non-Hodgkin's lymphoma
- No concurrent systemic corticosteroids
- Concurrent topical and/or oral antifungal agents permitted
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114-2617
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
University Hospital/New Jersey Cancer Center
Newark, New Jersey, 07103
San Francisco General Hospital Medical Center
San Francisco, California, 94110
About this study
Official title: A Randomized Pre-Phase II Trial of Interleukin-2, Interleukin-12, or No Additional Therapy Following Response to Ifosfamide/Etoposide Chemotherapy for Refractory HIV-Associated Non-Hodgkin's Lymphoma
Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in treating patients who have refractory HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person' white blood cells to kill cancer cells.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of interleukin-12 (IL-12) by evaluating its effect on remission duration after response to second line chemotherapy with ifosfamide and etoposide in patients with HIV-associated non-Hodgkin's lymphoma.
II. Determine the safety of IL-12 when administered as maintenance therapy in these patients.
III. Evaluate overall survival of this patient population. IV. Evaluate serum and tissue cytokine levels in these patients. V. Evaluate the effect of IL-12 on HIV viral load and on functional T-cell assays in these patients.
VI. Evaluate the effect of IL-12 on Epstein-Barr Virus (EBV) viral load in these patients.
OUTLINE: This is an open label study.
All patients receive ifosfamide IV by continuous infusion for 2 days, etoposide IV over 2 hours daily on days 1 and 2, and filgrastim (G-CSF) subcutaneously (SC) daily on days 4-13. Courses are repeated every 21 days. Patients who have complete or partial remission after a minimum of 4 courses of chemotherapy receive maintenance therapy consisting of interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and continuing for 6 months or until disease progression. All patients also receive combination antiretroviral therapy during study.
Patients are followed every month for one year, then every 2 months thereafter.
- Conditions
- Lymphoma
- Being tested
- filgrastim, recombinant interleukin-12, etoposide, ifosfamide
- Keywords
- AIDS-related peripheral/systemic lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
recombinant interleukin-12Biological
etoposideDrug
ifosfamideDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | All patients receive ifosfamide IV by continuous infusion for 2 days, etoposide IV over 2 hours daily on days 1 and 2, and filgrastim (G-CSF) subcutaneously (SC) daily on days 4-13. Courses are repeated every 21 days. Patients who have complete or partial remission after a minimum of 4 courses of chemotherapy receive maintenance therapy consisting of interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and continuing for 6 months or until disease progression. All patients also receive combination antiretroviral therapy during study. Receives: Biological: filgrastim; Biological: recombinant interleukin-12; Drug: etoposide; Drug: ifosfamide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2004 (estimated)
- Study startJan 1999
- Primary completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lawrence D. Kaplan, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003575
- Sponsor's protocol ID
- NCI-2012-02276
- Other IDs
- AMC-008, CDR0000066642
- Status last verified
- Oct 2002
- First submitted
- 1 Nov 1999
- Last updated
- 8 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pre-Phase II Trial of Interleukin-2, Interleukin-12, or No Additional Therapy Following Response to Ifosfamide/Etoposide Chemotherapy for Refractory HIV-Associated Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00003575
- Acronym / sponsor ID
- NCI-2012-02276
- Conditions
- Lymphoma
- Keywords
- AIDS-related peripheral/systemic lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 1999
- Primary completion
- Apr 2002 (actual)
- First posted
- 20 May 2004 (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.
Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in treating patients who have refractory HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person' white blood cells to kill cancer cells.
Detailed description
OBJECTIVES:
- Determine the efficacy of interleukin-12 (IL-12) by evaluating its effect on remission duration after response to second line chemotherapy with ifosfamide and etoposide in patients with HIV-associated non-Hodgkin's lymphoma.
II. Determine the safety of IL-12 when administered as maintenance therapy in these patients.
III. Evaluate overall survival of this patient population. IV. Evaluate serum and tissue cytokine levels in these patients. V. Evaluate the effect of IL-12 on HIV viral load and on functional T-cell assays in these patients.
VI. Evaluate the effect of IL-12 on Epstein-Barr Virus (EBV) viral load in these patients.
OUTLINE: This is an open label study.
All patients receive ifosfamide IV by continuous infusion for 2 days, etoposide IV over 2 hours daily on days 1 and 2, and filgrastim (G-CSF) subcutaneously (SC) daily on days 4-13. Courses are repeated every 21 days. Patients who have complete or partial remission after a minimum of 4 courses of chemotherapy receive maintenance therapy consisting of interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and continuing for 6 months or until disease progression. All patients also receive combination antiretroviral therapy during study.
Patients are followed every month for one year, then every 2 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: filgrastim, Biological: recombinant interleukin-12, Drug: etoposide, Drug: ifosfamideAll patients receive ifosfamide IV by continuous infusion for 2 days, etoposide IV over 2 hours daily on days 1 and 2, and filgrastim (G-CSF) subcutaneously (SC) daily on days 4-13. Courses are repeated every 21 days. Patients who have complete or partial remission after a minimum of 4 courses of chemotherapy receive maintenance therapy consisting of interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and continuing for 6 months or until disease progression. All patients also receive combination antiretroviral therapy during study. |
Who may qualify
- Ages
- 18 to 70 years
- 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 |
|---|---|---|
| filgrastim | Biological | Arm I |
| recombinant interleukin-12 | Biological | Arm I |
| etoposide | Drug | Arm I |
| ifosfamide | Drug | Arm I |
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 8 Feb 2013.
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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.
Lawrence D. Kaplan, MD study chair
University of California, San Francisco
10 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 filgrastim, recombinant interleukin-12 and etoposide in people with Lymphoma, run by National Cancer Institute (NCI) at 10 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?
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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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 8 Feb 2013.