Combination Chemotherapy and Rituximab in Treating Patients With Previously Untreated AIDS-Related Non-Hodgkin's Lymphoma - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020384

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.

Condition	Intervention	Phase
Lymphoma	Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Short-Course EPOCH-Rituximab For Untreated CD-20+ HIV-Associated Lymphomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cyclophosphamide Vincristine Doxorubicin Doxorubicin hydrochloride Etoposide Etoposide phosphate Filgrastim Rituximab Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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:	43
Study Start Date:	November 2000
Estimated Primary Completion Date:	June 2001 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	9 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020384

Locations

United States, Maryland
NCI - Center for Cancer Research	Recruiting
Bethesda, Maryland, United States, 20892
Contact: Clinical Trials Office - NCI - Center for Cancer Research 888-624-1937
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892
Contact: Warren Grant Magnuson Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Wyndham H. Wilson, MD, PhD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NCI - Center for Cancer Research ( Wyndham Hopkins Wilson )
Study ID Numbers:	CDR0000068357, NCI-01-C-0030, NCI-2890
Study First Received:	July 11, 2001
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00020384 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
AIDS-related immunoblastic large cell lymphoma

AIDS-related small noncleaved cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related lymphoblastic lymphoma

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Therapeutic Uses
Etoposide
Lymphoma
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Rituximab
Mitosis Modulators

Vincristine
Antimitotic Agents
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 08, 2010