Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00562068
First received: November 20, 2007
Last updated: August 23, 2013
Last verified: November 2008
  Purpose

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 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 trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Biological: alemtuzumab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisolone
Drug: vincristine sulfate
Genetic: polymerase chain reaction
Other: flow cytometry
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Immediate toxicity (incidence of infusion-related reactions) [ Designated as safety issue: Yes ]
  • Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L) [ Designated as safety issue: Yes ]
  • Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease response (remission rate [complete response and partial response]) [ Designated as safety issue: No ]
  • Disease outcome (time to progression and overall survival at 2 years from completion of therapy) [ Designated as safety issue: No ]
  • Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L) [ Designated as safety issue: No ]
  • Relative dose intensity [ Designated as safety issue: No ]
  • Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment [ Designated as safety issue: No ]
  • Epstein-Barr virus copy number (measured retrospectively) [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2007
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the feasibility of adding alemtuzumab to standard cyclophosphamide, doxorubicin hydrochloride, vincristine, and oral prednisolone (CHOP) chemotherapy in patients with stage I-IV peripheral T-cell lymphoma (PTCL).
  • To assess the side effect profile and early and late toxicities of this regimen in a standard dose-escalation design, and to establish an appropriate dose level for future studies.

Secondary

  • To document response rates and disease-free survival of patients treated with this regimen, and to compare these findings with those of historical controls.
  • To monitor immune reconstitution after therapy.
  • To determine the pharmacokinetics of subcutaneous alemtuzumab when given in combination with CHOP chemotherapy.
  • To more clearly define the CD52 expression profile in these tumors and to investigate phenotypic variations in PTCL.
  • To document changes (if any) in levels of Epstein-Barr virus copy number by polymerase chain reaction during CHOP-alemtuzumab therapy.

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

Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive alemtuzumab subcutaneously (SC) 1-3 times a week for up to 6 doses per course. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline, periodically during study treatment, and after completion of study therapy for pharmacokinetics and other correlative studies to monitor cellular immunity. Blood samples are examined by polymerase chain reaction to detect cytomegalovirus antigen and to monitor Epstein-Barr virus copy number. Samples are also analyzed by flow cytometry to quantify circulating B- and T-cells, NK-cells, monocytes, and dendritic-cells.

After completion of study therapy, patients are followed every 3 months for the first year, every 6 months for the second year, and then yearly thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of peripheral T-cell lymphoma (PTCL), including the following subtypes:

    • PTCL not otherwise specified
    • Angioimmunoblastic T-cell lymphoma
    • Anaplastic lymphoma kinase-negative anaplastic large cell lymphoma
    • Intestinal T-cell lymphoma
  • Bulky stage IA and stages IB-IV disease (Ann Arbor staging system)
  • Expression of CD52 by the tumor
  • Measurable or evaluable disease
  • No anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma
  • No CNS involvement with non-Hodgkin lymphoma

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • No presence of other serious, uncontrolled medical conditions
  • No significant anthracycline-related cardiac impairment
  • LVEF ≥ 50%
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 2 times normal value unless due to disease
  • Not pregnant or nursing
  • Fertile patients must use effective barrier contraception during and for 1 month after completion of study treatment
  • No previous malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
  • No positive serology or non-consenting to test for any of the following:

    • HIV
    • Hepatitis B or C
    • Human T-lymphotropic virus type 1 (HTLV-1)

PRIOR CONCURRENT THERAPY:

  • No prior cytotoxic chemotherapy
  • Prior radiotherapy may be allowed at the trial coordinator's discretion
  • Concurrent consolidation radiotherapy may be given at the clinician's discretion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562068

Locations
United Kingdom
Leeds General Infirmary Recruiting
Leeds, England, United Kingdom, LS1 3EX
Contact: Contact Person    44-113-392-3766      
King's College Hospital Recruiting
London, England, United Kingdom, SE5 9RS
Contact: Contact Person    44-20-3299-9000      
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Contact Person    44-20-7352-8171      
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Contact Person    44-161-446-8565      
Torbay Hospital Recruiting
Torbay Devon, England, United Kingdom, TQ2 7AA
Contact: Contact Person    44-180-365-5260      
Sponsors and Collaborators
Cancer Research UK
Investigators
Study Chair: Roderick Johnson, MD Leeds General Infirmary
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562068     History of Changes
Other Study ID Numbers: CDR0000576439, UCL-BRD/05/170, EU-20785, EUDRACT-2006-000365-11, CTA 21786/0201/001-0001, CRUK-UCL-BRD/05/170-CHOP-CAMPA, UCL-CHOP-CAMPATH
Study First Received: November 20, 2007
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult T-cell leukemia/lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
small intestine lymphoma
peripheral T-cell lymphoma

Additional relevant MeSH terms:
Jejunal Diseases
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Ileal Diseases
Cyclophosphamide
Campath 1G
Alemtuzumab
Doxorubicin
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine

ClinicalTrials.gov processed this record on July 24, 2014