View Clinical Trial (Medical Research Study)
Short-Course EPOCH-Rituximab for Untreated CD-20+ HIV-Associated Lymphomas
| City: |
|
Bethesda |
| State: |
|
Maryland |
| Zip Code: |
|
20892 |
| Conditions: |
|
AIDS Related Lymphoma - HIV Infection |
| Purpose: |
|
Background:
- HIV-infected patients have a weakened immune system, and chemotherapy, which is used to
treat lymphoma, probably causes further damage to the immune system.
- Limiting the amount of immune damage due to chemotherapy might decrease the number of
infections and the risk of developing cancer in the future in HIV-infected patients
with non-Hodgkin's lymphoma.
Objectives:
- To determine whether reducing the total amount of chemotherapy using a specific
combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine,
cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing
the risk of infections and future cancers.
- To determine whether the lymphoma will remain undetectable for at least one year if
treatment is stopped one cycle after the patient enters remission.
Eligibility:
-Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have
not been treated previously with rituximab or cytotoxic chemotherapy.
Design:
- Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than
six cycles.
- The lymphoma is evaluated using CT and PET scans at the end of treatment cycles 2 and
3. A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on
screening for participation in the study.
- Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R
treatment ends.
- Patients are monitored for treatment response with blood tests and imaging scans at
baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6
months for a total of 24 months following chemotherapy.
|
| Study Summary: |
|
Background:
This is a study to investigate in a preliminary fashion the feasibility of short course
chemotherapy to patients with HIV-associated non-Hodgkin's lymphoma (HIV-NHL).
This study will investigate if the paradigm for treatment can be successfully changed from a
standard of 6 cycles to one cycle beyond complete remission with 6 total allowable cycles.
Objectives:
To assess with 90 percent probability that at least 50 percent of patients treated with
short-course EPOCH-R will be progression free at one year.
Assess toxicity of SC-EPOCH-R.
Assess response rate and duration of SC-EPOCH-R.
Assess the utility of PET scans to predict freedom from relapse with SC-EPOCH-R.
Assess effects SC-EPOCH-R on CD4 cell depletion and recovery.
Assess response to antiretroviral therapy following SC-EPOCH-R.
Eligibility:
Aggressive CD20 positive DLBCL.
HIV+ serology.
All stages (I-IV) of disease.
ECOG Performance status 0-4.
NHL previously untreated with cytotoxic chemotherapy.
Age greater than or equal to 4 years.
May not be pregnant or nursing.
May not have received previous rituximab.
Design:
Patients will be treated every three weeks with a combination of EPOCH and rituximab for one
cycle beyond CR/CRu by CT scan of all detectable tumors for a minimum of three and maximum
of six cycles. Following cycle 2, CT, positron emission tomography scans (PET), and bone
marrow biopsies (if initially positive) will be performed.
At the conclusion of the study, we will estimate whether the number of cycles can be reduced
using the paradigm. If the cumulative number of patients to relapse exceeds 25 percent by 6
months, the study will be closed.
Following the completion of chemotherapy, restaging will be performed 2 months following the
end of treatment, then every 3 months for one year, every 6 months for one year, then every
12 months until relapse, death, or loss to follow up.
Anti-HIV therapy will be suspended prior to initiation of the chemotherapy and optimum
therapy will be reinitiated after all the cycles have been administered.
To study the effects of treatment approach on parameters of HIV disease, measurements of CD4
cells and viral loads will be made at baseline and at the completion of therapy, and then 2
months following the end of treatment, and then every 3-6 months for a total of 24 months
following chemotherapy.
|
| Criteria: |
|
- INCLUSION CRITERIA:
Aggressive CD20 positive Diffuse Large B-cell lymphoma confirmed by Laboratory of
Pathology, NCI.
HIV + serology.
All stages (I-IV) of disease.
ECOG Performance status 0-4
NHL previously untreated with cytotoxic chemotherapy.
Age greater than or equal to 4 years
Laboratory tests (unless impairment due to respective organ involvement by tumor):
-Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal
to 50 ml/min
Pediatric patients: Age-adjusted normal serum creatinine according to the following table
or a creatinine clearance greater than 60 ml/min/1.73 m(2).
Less than or equal to 5 age (years), 0.8 Maximum serum creatinine
Greater than 5, less than or equal to 10 age (years), 1.0 Maximum serum creatinine
Greater than 10, less than or equal to 15 age (years), 1.2 Maximum serum creatinine
Greater than 15 age (years), 1.5 Maximum serum creatinine
- Bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl
with direct fraction less than or equal to 0.3 mg/dl in patients for whom these
abnormalities are felt to be due to protease inhibitor therapy
- AST and ALT less than or equal to 3x ULN (AST and ALT less than or equal to 6x ULN
for patients on hyperalimentation for whom these abnormalities are felt to be due to
the hyperalimentation)
- ANC greater than or equal to 1000/mm(3)
- Platelet greater than or equal to 75,000/mm(3) (unless impairment due to ITP)
Ability of patient or parent/guardian to provide informed consent.
EXCLUSION CRITERIA:
Previous rituximab
Pregnancy or nursing.
- Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be
excreted in milk.
- Antiretroviral therapy is indicated during pregnancy and nursing.
Current clinical heart failure or symptomatic ischemic heart disease.
Serious underlying medical condition or infection other than HIV that would contraindicate
SC-EPOCH-R.
- Examples include, but are not limited to:
- Severe AIDS-related wasting
- Sever intractable diarrhea
- Active inadequately treated opportunistic infection of the CNS
Concurrent anti-retroviral therapy during EPOCH therapy.
Primary CNS lymphoma.
Adolescents who do not freely assent
|
| NCT ID: |
|
NCT00006436 |
| Primary Contact: |
|
Principal Investigator
Wyndham H Wilson, M.D.
National Cancer Institute (NCI)
Margaret Shovlin, R.N.
Phone: (301) 594-6597
Email: mshovlin@mail.nih.gov
|
| Backup Contact: |
|
Email: wilsonw@box-w.nih.gov
Wyndham H Wilson, M.D.
Phone: (301) 435-2415
|
| Location Contact: |
|
Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: (888) NCI-1937
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 19, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|