Alemtuzumab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV T-Cell Non-Hodgkin's Lymphoma

NCT00363090 | Unknown Phase 1

• 2 other identifiers: CDR0000491451TSRCC-164-2006
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed aggressive stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma

Outcome Measures

Primary Outcomes (4)

• Toxicity as assessed by NCI Common Toxicity Criteria Version 3.0

• Safety

• Dose-limiting toxicities

• Pharmacokinetics of alemtuzumab

Secondary Outcomes (5)

• Efficacy as assessed by clinical, radiologic, pathologic, and laboratory measurements

• Overall response rate

• Progression-free survival

• Overall survival

• Effects of treatment on T- and B-cell reconstitution by flow cytometry at baseline and at 3, 6, and 12 months

Interventions

alemtuzumab BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

prednisone DRUG

vincristine sulfate DRUG

flow cytometry OTHER

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed aggressive peripheral T-cell non-Hodgkin's lymphoma (NHL), including the following nodal or extranodal subtypes: * Nodal: * Angioimmunoblastic lymphadenopathy * ALK 1-negative anaplastic large cell NHL * Peripheral T-cell lymphoma not otherwise specified * Extranodal: * Hepatosplenic NHL * Enteropathy-associated NHL * Panniculitic NHL * Stage II-IV disease * Newly diagnosed, CD52+ disease * Measurable or evaluable disease * No known CNS involvement with lymphoma * No nasal natural killer T-cell NHL PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 4 months * Absolute neutrophil count ≥ 1,000/mm³\* * Platelet count ≥ 75,000/mm³\* * Hemoglobin ≥ 8.5 g/dL\* * Bilirubin \< 2.0 mg/dL * Alkaline phosphatase ≤ 2 times upper limit of normal (ULN) * AST or ALT \< 2 times ULN * Creatinine \< 1.5 mg/dL\* * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to any of the study drugs * No serious illnesses that would preclude compliance with study requirements * No known HIV positivity * No other preexisting immunodeficiency (e.g., post-organ transplant) * No other malignancy within the past 5 years except cervical carcinoma in situ or nonmelanoma skin cancer NOTE: \*Unless directly attributable to NHL PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * Up to 7 days of prednisone preceding initiation of chemotherapy allowed * No other concurrent chemotherapy, radiotherapy, or immunotherapy * No other concurrent corticosteroids except dexamethasone used as an antiemetic for a brief period

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Toronto Sunnybrook Regional Cancer Centre: lead

Study Sites (5)

St. Paul's Hospital at Providence Health Care - Vancouver

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, N6A 4L6, Canada

RECRUITING

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

RECRUITING

Odette Cancer Centre at Sunnybrook

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Alemtuzumab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine; Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphadenopathy; Lymphoma, T-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Rena Buckstein, MD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2010
• Last Updated: September 20, 2013

Record last verified: 2009-06

Locations

CA (5)