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CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas
This study is currently recruiting participants.
Verified by Ohio State University Comprehensive Cancer Center, December 2007
First Received: May 8, 2006   Last Updated: December 27, 2007   History of Changes
Sponsored by: Ohio State University Comprehensive Cancer Center
Information provided by: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00323323
  Purpose

Purpose: This study will evaluate the safety of CHOP plus Alemtuzumab in patients with T/NK cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous treatments. The biological response of lymphoma cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Alemtuzumab
Phase I

MedlinePlus related topics: Lymphoma
Drug Information available for: Cyclophosphamide Prednisone Vincristine Doxorubicin Doxorubicin hydrochloride Myocet Campath Alemtuzumab Vincristine sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Week 1 and Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: March 2004
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cyclophosphamide
    750 mg/m2 IV on Day 1 every 3 weeks x 8.
    Drug: Doxorubicin
    50 mg/m2 IV on Day 1 every 3 weeks x 8.
    Drug: Vincristine
    1.4 mg/m2 (maximum dose = 2 mg) IV on Day 1 every 3 weeks x 8.
    Drug: Prednisone
    100 mg orally on Days 1-5 every 3 weeks x 8.
    Drug: Alemtuzumab
    Cohort 1 = 3 mg SQ Day 1 every 3 weeks x 8. Cohort 2 = 10 mg SQ Day 1 every 3 weeks x 8. Cohort 3 = 20 mg SQ Day 1 every 3 weeks x 8. Cohort 4 = 30 mg SQ Day 1 every 3 weeks x 8.
Detailed Description:

Rationale: The drug combination called CHOP, or Cyclophosphamide (Cytoxan), Doxorubicin (Adriamycin), Vincristine (Oncovin), and Prednisone (Deltasone), has been used against different types of lymphoma for many years. Researchers are investigating what other therapies to combine with the CHOP regimen to improve outcomes for patients with lymphoma. The current study combines CHOP with alemtuzumab, a monoclonal antibody used against leukemia. Monoclonal antibodies are a type of immunotherapy used against some types of cancer. They are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins. Alemtuzumab is designed to target leukemia cells that express a specific protein. The specific protein recognized by alemtuzumab is the CD52 antigen. This antigen, or substance that causes the immune system to create a specific response, is expressed on normal B and T cells, as well as on abnormal T cells characteristic of certain cancers. Alemtuzumab causes the CD52 antigen to bind with B-cell lymphocytes. This study will also assess the theory that alemtuzumab may increase the effectiveness of the chemotherapy agents included in the CHOP regimen.

Treatment: Patients in this study will receive alemtuzumab and CHOP. Alemtuzumab will be given through injections into the skin and CHOP will be administered through intravenous infusions. Patients will receive alemtuzumab alone during the first week of the study. An increasing amount of alemtuzumab will be given during the first week. If patients cannot tolerate the highest amount of alemtuzumab determined as appropriate within one week, they will be removed from the study. Once the highest dose of alemtuzumab has been achieved, patients will then receive both alemtuzumab and CHOP every three weeks. This schedule will be repeated up to eight times. Several tests and exams will be given throughout the study to closely monitor patients.

Treatments will be discontinued due to disease growth or unacceptable side effects.

  Eligibility

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

Inclusion Criteria:

  • CD-20 Negative
  • Previous treatment permitted: radiation, electron beam radiotherapy, PUVA, corticosteroids, IFN, low dose methotrexate, retinoids, Ontak
  • CNS disease permitted

Exclusion Criteria:

  • Pregnant or Nursing
  • prior Alemtuzumab
  • history of active Hep C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323323

Contacts
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com

Locations
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Pierluigi Porcu Ohio State University
  More Information

No publications provided

Responsible Party: Ohio State University Comprehensive Cancer Center ( Pierluigi Porcu, M.D. )
Study ID Numbers: OSU-0303
Study First Received: May 8, 2006
Last Updated: December 27, 2007
ClinicalTrials.gov Identifier: NCT00323323     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:
Untreated
CD-20 Negative
Large B-Cell Lymphomas

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Hormones
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, B-Cell
Anti-Bacterial Agents
Alemtuzumab
Aggression
Lymphoma
Alkylating Agents
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Glucocorticoids
Doxorubicin
Lymphatic Diseases
B-cell Lymphomas
Tubulin Modulators
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Alemtuzumab
Therapeutic Uses
Lymphoma
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Vincristine
Antimitotic Agents
Glucocorticoids
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on May 07, 2009