This trial is active, not recruiting.

Condition lymphoma
Treatment alefacept
Phase phase 1
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date March 2006
End date July 2010
Trial size 24 participants
Trial identifier NCT00438802, 06-002246, CDR0000530071, LS058C, P30CA015083, P50CA097274


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Determine both the maximum tolerated dose level as well as the optimal immunologic dose and toxicity.
alefacept Amevive
Dose escalation theme. 0.075mg/kg by IV Weekly x 8 to 0.30mg/kg IV Weekly x 8

Primary Outcomes

time frame: 9/21/2006 - 7/06/2010
time frame: 9/22/2006 - 6/08/2010

Secondary Outcomes

Clinical response
time frame: 1/05/2007 - 2/25/2011

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-cell Lymphoma and Peripheral T-cell NHL
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.