EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
This study is currently recruiting participants.
Verified October 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00006436
First received: November 3, 2000
Last updated: December 8, 2012
Last verified: October 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
AIDS Related Lymphoma HIV Infection |
Biological: Rituximab Biological: filgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Short-Course EPOCH-Rituximab for Untreated CD-20+ HIV-Associated Lymphomas |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Cyclophosphamide
Vincristine sulfate
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Rituximab
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- Progression-free survival at 1 year after completion of study treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity during and 1 year after completion of study treatment. [ Designated as safety issue: Yes ]
- Response rate and duration at completion of study treatment and 5 years later. [ Designated as safety issue: No ]
- Ability of positron emission tomography (PET) scans to predict freedom from relapse at completion of study treatment and 5 years later. [ Designated as safety issue: No ]
- Effects of short course etoposide, vincristine, cyclophosphamide, doxorubicin, and rituximab (SC-EPOCH-R) on CD4 cell depletion and recovery at completion of study treatment and 18 months later. [ Designated as safety issue: No ]
- Response to antiretroviral therapy following SC-EPOCH-R 18 months after completion of study treatment. [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2000 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Biological: Rituximab
N/A
Biological: filgrastim
N/A
Drug: cyclophosphamide
N/A
Drug: doxorubicin hydrochloride
N/A
Drug: etoposide
N/A
Drug: vincristine sulfate
N/A
Show Detailed Description Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006436
Contacts
| Contact: Margaret Shovlin, R.N. | (301) 594-6597 | mshovlin@mail.nih.gov |
| Contact: Wyndham H Wilson, M.D. | (301) 435-2415 | wilsonw@box-w.nih.gov |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Wyndham H Wilson, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) |
| ClinicalTrials.gov Identifier: | NCT00006436 History of Changes |
| Obsolete Identifiers: | NCT00020384 |
| Other Study ID Numbers: | 010030, 01-C-0030 |
| Study First Received: | November 3, 2000 |
| Last Updated: | December 8, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
AIDS Malignancy Antiretroviral Chemotherapy Monoclonal |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lymphoma Lymphoma, Non-Hodgkin Lymphoma, AIDS-Related Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Lymphoma, B-Cell Cyclophosphamide Rituximab Doxorubicin Etoposide Vincristine Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on February 24, 2013
