ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma

This study is currently recruiting participants.
Study NCT00438802.   Last updated on October 29, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma
Official Title  A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-Cell Lymphoma and Peripheral T-Cell NHL
Brief Summary

RATIONALE: Combinations of biological substances in alefacept may be able to carry cancer-killing substances directly to cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose or the optimal immunologic dose of alefacept in patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma.

Secondary

  • Determine if antitumor activity of this drug exists in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

  • Induction therapy: Patients receive alefacept IV over 2-5 minutes once weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or complete or partial response after induction therapy proceed to maintenance therapy.

Cohorts of 6 patients receive escalating doses of alefacept until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The optimal immunologic dose is defined as the dose that does not exceed the MTD, has the highest alefacept level, and achieves saturation of CD2 receptors.

  • Maintenance therapy: Patients receive alefacept IV on day 1. Treatment repeats every 4 weeks for 10-12 courses in the absence of disease progression or unacceptable toxicity.

Patients who experience disease progression during maintenance therapy may receive reinduction therapy* comprising 4 weekly doses of alefacept. The patient then proceeds to a second maintenance phase in the absence of disease progression.

NOTE: *Only 1 reinduction allowed.

Patients undergo blood and tissue collection periodically for pharmacological studies. Blood serum is analyzed for alefacept concentration, cytokine concentration, CD16 polymorphisms, and CD2 saturation via flow cytometry.

After completion of study treatment, patients are followed every 3 months for up to 3 years and then periodically thereafter.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure  Tolerability [ Designated as safety issue: Yes ]
Immunostimulation [ Designated as safety issue: No ]
Secondary Outcome Measure  Clinical response [ Designated as safety issue: No ]
Condition  Lymphoma
Intervention  Drug: alefacept
Procedure: flow cytometry
Procedure: pharmacological study
Procedure: polymorphism analysis
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  24
Start Date  March 2006
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically confirmed cutaneous T-cell lymphoma (CTCL) or peripheral T-cell non-Hodgkin's lymphoma

    • Diagnostic biopsies must have been obtained within the past 6 months
  • Relapsed or refractory disease

    • Patients with CTCL must have failed ≥ 2 skin-directed therapies

      • No limit on the number of prior therapies
  • Measurable disease, defined as at least 1 bidimensionally measurable lesion > 2 cm by CT scan, MRI, physical exam, or photograph with appended ruler

    • At least 2 bidimensionally measurable target lesions required for patients with skin lesions only
  • No CNS lymphoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times ULN
  • AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)
  • Creatinine ≤ 2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to provide all research blood samples as required by the protocol
  • Willing to undergo repeat biopsy of either an accessible skin lesion or lymph node, if there are no circulating sezary cells, for the purpose of research studies (patients without easily accessible lesions are not required to have a repeat biopsy solely for research purposes but must be willing to provide a portion of the on-study biopsy or a previous lymphoma biopsy, if available)
  • No known congenital or acquired immunodeficiency syndromes, including HIV
  • No known active viral hepatitis or tuberculosis infection
  • No uncontrolled infection
  • No other uncontrolled serious medical condition unrelated to lymphoma (e.g., cardiac arrhythmia or diabetes)
  • No other active malignancies
  • No history of serious allergic reaction to citrate or glycine

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 3 weeks since prior cytotoxic chemotherapy
  • More than 3 weeks since prior denileukin diftitox
  • More than 3 weeks since prior radiotherapy (less than 3 weeks if the acute side effects of this therapy are resolved)
  • More than 2 weeks since prior oral corticosteroids (unless being used to treat adrenal insufficiency)
  • More than 2 weeks since prior phototherapy, including ultraviolet B and psoralen with ultraviolet A
  • More than 1 week since prior biologic therapy
  • No concurrent chemotherapy, other immunotherapy, or radiotherapy
  • No other concurrent investigational agents
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00438802
Organization ID CDR0000530071
Secondary IDs †† MAYO-LS058C, MAYO-06-002246
Study Sponsor  Mayo Clinic
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Thomas E. Witzig, MD     Mayo Clinic    
Investigator:     Mark R. Pittelkow, MD     Mayo Clinic    
Investigator:     Brian Link, MD     Holden Comprehensive Cancer Center    
Investigator:     Yvette L. Kasamon, MD     Sidney Kimmel Comprehensive Cancer Center    
Investigator:     Jasmine M. Zain, MD     Beckman Research Institute    
Information Provided By National Cancer Institute (NCI)
Verification Date March 2008
First Received Date  February 20, 2007
Last Updated Date October 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers