DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: Alefacept (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Thomas E. Witzig, MD, Study Chair, Affiliation: Mayo Clinic

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.

Clinical Details

Official title: A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-cell Lymphoma and Peripheral T-cell NHL

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Tolerability

Immunostimulation

Secondary outcome: Clinical response

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 52242-1002, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2006
Last updated: June 23, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017