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Alemtuzumab Combined With Etoposide, Vincristine, Doxorubicin, Cyclophosphamide, and Prednisone in Treating Patients Who Have Not Received Chemotherapy For T-Cell or NK-Cell Lymphoma

2014-08-27 03:54:47 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy in treating patients who have not previously received chemotherapy for T-cell or NK-Cell lymphoma.

Description

OBJECTIVES:

Primary

- Determine the toxicity of alemtuzumab and etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH) in patients with chemotherapy-naïve CD52-expressing aggressive T- or NK-cell lymphoma.

- Determine the maximum tolerated dose of alemtuzumab when administered with EPOCH chemotherapy in these patients.

Secondary

- Determine, preliminarily, the antitumor activity of this regimen in these patients.

OUTLINE: This is a pilot, dose-escalation study of alemtuzumab.

Patients receive alemtuzumab IV over 12 hours on day 1 and EPOCH chemotherapy comprising etoposide IV, doxorubicin IV, and vincristine IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 15 minutes on day 5; and oral prednisone twice daily on days 0-5. Patients also receive filgrastim subcutaneously on day 6. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of alemtuzumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued to this study within 2.5 years.

Study Design

Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

alemtuzumab, filgrastim, cyclophosphamide, doxorubicin hydrochloride, etoposide, prednisone, vincristine sulfate

Location

NCI - Center for Cancer Research
Bethesda
Maryland
United States
20892

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:47-0400

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Medical and Biotech [MESH] Definitions

A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.

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Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.

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An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.

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