Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00958854
First received: August 12, 2009
Last updated: August 23, 2013
Last verified: August 2009
  Purpose

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the cancer. Giving fludarabine and cyclophosphamide together with thalidomide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with thalidomide works in treating patients with angioimmunoblastic T-cell lymphoma.


Condition Intervention Phase
Lymphoma
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: thalidomide
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate after chemotherapy with fludarabine and cyclophosphamide [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incremental response rate to thalidomide treatment [ Designated as safety issue: No ]
  • Toxicity according to the NCI CTCAE v.3.0 [ Designated as safety issue: Yes ]
  • Progression-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: January 2006
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with angioimmunoblastic T-cell lymphoma after chemotherapy comprising fludarabine and cyclophosphamide.

Secondary

  • Assess the incremental anatomical and molecular response rate in these patients during treatment with thalidomide.
  • Determine the toxicity of treatment with fludarabine and cyclophosphamide followed by thalidomide.
  • Assess the progression-free and overall survival of these patients.
  • Develop a detailed pathological description of the disease at presentation and at relapse.
  • Assess the number of circulating clonal T cells at presentation and during thalidomide treatment.
  • Screen for possible etiological viruses at presentation.
  • Evaluate the evolution of EBV viral load during follow-up.

OUTLINE: This is a multicenter study.

Patients receive oral or IV fludarabine and oral or IV cyclophosphamide once daily on days 1-3. Courses repeat every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Beginning at least 4 weeks after completion of chemotherapy, patients who achieve at least stable disease receive oral thalidomide once daily for at least 6 months.

Lymph nodes, marrow, and peripheral blood will be collected periodically for research studies.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Newly diagnosed angioimmunoblastic T-cell lymphoma
  • Measurable disease (i.e., anatomically assessable)

PATIENT CHARACTERISTICS:

  • WHO/ECOG performance status 0-2
  • Serum creatinine ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception before, during, and after study treatment
  • No known seropositivity for hepatitis B virus, hepatitis C virus, or HIV
  • No active second malignancy or other concomitant serious medical condition, in particular peripheral neuropathy

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for angioimmunoblastic T-cell lymphoma
  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: NCT00958854

Locations
United Kingdom
Cancer Research UK and University College London Cancer Trials Centre Recruiting
Exeter, England, United Kingdom, EX2 5DW
Contact: Claudius Rudin, MD    44-1392-402-850      
Sponsors and Collaborators
Cancer Research UK
Investigators
Principal Investigator: Claudius Rudin, MD Royal Devon and Exeter Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00958854     History of Changes
Other Study ID Numbers: CDR0000644123, CRUK-UCL-AITL, EUDRACT-2005-003931-40, EU-20947
Study First Received: August 12, 2009
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
angioimmunoblastic T-cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine phosphate
Thalidomide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on September 18, 2014