NIH Clinical Research Studies

Protocol Number: 03-C-0304

Active Accrual, Protocols Recruiting New Patients

Title:
Pilot Trial of Alemtuzumab and Dose-Adjusted Epoch in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas
Number:
03-C-0304
Summary:
This study will examine the safety and effectiveness of combination therapy with the monoclonal antibody Campath-1H and continuous infusion of a chemotherapy regimen called EPOCH for treating non-Hodgkin's T-cell and NK-cell lymphomas. In general, T-cell and NK-cell lymphomas are less responsive to standard treatments than B-cell lymphomas. EPOCH, which includes the drugs doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone, has shown a high degree of effectiveness in patients whose tumors have stopped responding to standard regimens. Campath-1H may improve the effects of chemotherapy.

Patients 17 years of age and older with T- or NK-cell non-Hodgkin's lymphoma whose disease is considered to be more amenable to chemotherapy than surgery or radiation may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, and electrocardiogram. Other tests that may be required include: lumbar puncture (spinal tap); imaging tests such as magnetic resonance imaging (MRI), positron emission tomography (PET), computed tomography (CT), and x-rays; and biopsy (surgical removal of a small tissue sample) of tumor, bone marrow, or other tissue.

Patients receive treatment in chemotherapy cycles that are repeated every 3 weeks. Drugs are administered during the first 5 days of the cycle, followed by 16 days of rest. The cycles are repeated until the tumor disappears (goes into remission) or shows no further signs of shrinking:

- Campath-1H, given by vein over about 12 hours on the first day of therapy, immediately before the chemotherapy infusion begins.

- Doxorubicin, etoposide, and vincristine, given by continuous IV infusion over 4 days, beginning on day 1 and ending on day 5 of each cycle. The drugs are delivered through a lightweight portable infusion pump to an indwelling IV catheter (plastic tube) in a vein.

- Cyclophosphamide, given by IV infusion over 15 minutes on day 5 of each cycle.

- Prednisone, given by mouth (pills) twice a day on days 1 through 5 of each cycle.

- Pegfilgrastim, given by injection under the skin once on day 6 of each cycle to help normal bone marrow cells recover from the chemotherapy and produce neutrophils, a type of white blood cell.

- G-CSF, given by injection under the skin once a day to boost white cell production.

- Patients also take a combination of antibiotics 3 days a week during EPOCH to prevent infection while resistance is lowered because of the chemotherapy.

Treatment continues for six to eight cycles, depending on the response to therapy. Patients who show no signs of disease at the end of treatment will be seen periodically at the Clinical Center for follow-up tests and examinations. Patients whose disease does not disappear entirely, gets worse, or recurs after having disappeared will be offered participation in other appropriate research protocols, if available, or will be returned to the care of the referring physician.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
ELIGIBILTY CRITERIA:

CD52-expressing lymphoid malignancy, confirmed by pathology or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology, NCI. Patients with T & NK cell malignancy without accessible tissue for flow cytometry analysis may be treated on this study.

Patients with chemotherapy naive aggressive T & NK lymphomas, including but not limited to peripheral T cell lymphoma (nos), gamma-delta hepatosplenic T cell lymphoma, subcutaneous panniculitis-like T cell, NK-T cell lymphoma confirmed by pathology or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology, NCI. Patients with alk-positive anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible.

Age greater than or equal to 17 years.

Laboratory tests: Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 ml/min; bilirubin less than 2.0 mg/dl unless due to Gilbert's, AST and ALT less than or equal to 3x ULN (AST and ALT is less than or equal to 6x ULN for patients on hyperalimentation) and; ANC is greater than or equal to 1000/mm(3), platelet greater than or equal to 75,000/mm(3); unless impairment due to respective organ involvement by tumor.

No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year.

HIV negative, because of the unknown effects of combined therapy with chemotherapy and an immunosuppressive agent on HIV progression.

Signed informed consent.

Willing to use contraception.

Not pregnant or nursing, because of the unknown effects of Alemtuzumab on the developing fetus and infant.

No serious underlying medical condition or infection that would contraindicate treatment. Patients with CNS involvement are eligible for treatment on this study.

Special Instructions: Currently Not Provided
Keywords:
Immunosuppression
CD52
Flow Cytometry
Campath 1-H
Recruitment Keywords:
Lymphoma
T-Cell Lymphoma
NK -Cell Lymphoma
Conditions:
Lymphoma
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Wing MG, Moreau T, Greenwood J, Smith RM, Hale G, Isaacs J, Waldmann H, Lachmann PJ, Compston A. Related Articles, Links Free Full Text Mechanism of first-dose cytokine-release syndrome by CAMPATH 1-H: involvement of CD16 (FcgammaRIII) and CD11a/CD18 (LFA-1) on NK cells. J Clin Invest. 1996 Dec 15;98(12):2819-26.

Harris NL, Jaffe ES, Stein H, Banks PM, Chan JK, Cleary ML, Delsol G, De Wolf-Peeters C, Falini B, Gatter KC. Related Articles, Links No abstract A revised European-American classification of lymphoid neoplasms: a proposal from the International Lymphoma Study Group. Blood. 1994 Sep 1;84(5):1361-92. Review. No abstract available.

A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood. 1997 Jun 1;89(11):3909-18.

Active Accrual, Protocols Recruiting New Patients

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