Combination Chemotherapy and Rituximab in Treating Patients With Previously Untreated AIDS-Related Non-Hodgkin's Lymphoma - NCT00020384-20892B (Clinical Trial 113526)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy113526.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Bethesda |
|
State:
|
|
MD |
| Zip Code: |
|
20892 |
| Conditions: |
|
Lymphoma |
| Purpose: |
|
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer
cells and either kill them or deliver cancer-killing substances to them without harming
normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy may
kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and rituximab
in treating patients who have previously untreated AIDS-related non-Hodgkin's lymphoma.
|
| Study summary: |
|
OBJECTIVES:
- Determine progression-free survival at 1 year in patients with previously untreated
AIDS-related non-Hodgkin's lymphoma treated with a minimum of 3 courses of etoposide,
vincristine, cyclophosphamide, doxorubicin, and rituximab.
- Determine the toxicity of this regimen in these patients.
- Determine the response rate and duration of response in these patients treated with
this regimen.
- Determine the effects of this regimen on CD4 cell depletion and recovery in these
patients.
- Assess the response of this patient population to antiretroviral therapy.
OUTLINE: Patients receive etoposide IV, doxorubicin IV, and vincristine IV continuously on
days 1-4, and cyclophosphamide IV over 30 minutes on day 5. Patients also receive rituximab
IV immediately prior to chemotherapy on days 1 and 5. Patients receive filgrastim (G-CSF)
subcutaneously beginning on day 6 and continuing until blood counts recover.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients achieving complete response receive 1 additional course.
After completion of study treatment, patients are followed at 2 months, every 3 months for 1
year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 28 months. |
| Criteria: |
|
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive CD20-positive non-Hodgkin's lymphoma (NHL)
- Any stage (I-IV) disease
- Positive HIV serology required
- No primary CNS lymphoma
PATIENT CHARACTERISTICS:
Age
- 9 and over
Performance status
- ECOG 0-4
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3 (unless impairment due to idiopathic
thrombocytopenic purpura)
Hepatic
- Bilirubin less than 2.0 mg/dL OR
- Total bilirubin no greater than 4.5 mg/dL (direct fraction no greater than 0.3 mg/dL
if impairment due to protease inhibitor therapy)
- AST and ALT no greater than 3 times upper limit of normal (ULN) (6 times ULN if
impairment due to hyperalimentation)
Renal
- Creatinine no greater than1.5 mg/dL OR
- Creatine clearance no greater than 50 mL/min
- Creatinine according to age as follows (pediatric patients only):
- 0.8 mg/dL (5 years and under)
- 1.0 mg/dL (6 to 10 years)
- 1.2 mg/dL (11 to 15 years)
- 1.5 mg/dL (15 years and over) OR
- Creatinine clearance greater than 60 mL/min (pediatric patients only)
Cardiovascular
- No current clinical heart failure or symptomatic ischemic heart disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious underlying medical condition that would preclude study participation
- No infection other than HIV that would preclude study participation
- No active inadequately treated opportunistic infection of the CNS
- No severe AIDS-related wasting
- No severe intractable diarrhea
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior rituximab
Chemotherapy
- No prior cytotoxic chemotherapy for NHL
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent antiretroviral therapy |
|
|
|
| Study is available at: |
|
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, MD 20892
United States
Primary Contact:
Warren Grant Magnuson Clinical Center
Phone: 888-NCI-1937 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
November 15, 2009 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|