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

NCT00438802 | Completed Phase 1 Results DMC

• 5 other identifiers: CDR0000530071P50CA097274P30CA015083LS058C06-002246
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphoma

Keywords

recurrent cutaneous T-cell non-Hodgkin lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma; adult nasal type extranodal NK/T-cell lymphoma; recurrent mycosis fungoides/Sezary syndrome

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on toxicities encountered during the first 8 weeks of treatment.\> \> For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria:\> * grade 4 toxicity for neutrophils (\<0.5 x 109/L) or platelets (\<25 x 109/L)\> * any grade 3 or higher solid organ toxicity not explainable by another obvious cause.\> * more than 10 x ULN AST toxicity for more than 14 days\> * any grade 4 infection.\> The number of patients who reported a dose limiting toxicity is reported here.

  8 weeks from registration

• Maximum Tolerated Dose (MTD)

  The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on DLT toxicities encountered during the first 8 weeks of treatment reported in Primary Outcome Measure #1.

  8 weeks from registration

Secondary Outcomes (1)

• Clinical Response

  up to 12 cycles (28 days per cycle) of treatment.

Study Arms (1)

alefacept

EXPERIMENTAL

Determine both the maximum tolerated dose level as well as the optimal immunologic dose and toxicity.

Drug: Alefacept

Interventions

Alefacept DRUG

Dose escalation theme. 0.075mg/kg by IV Weekly x 8 to 0.30mg/kg IV Weekly x 8

Also known as: Amevive

alefacept

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, T-Cell, Cutaneous; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Extranodal NK-T-Cell; Mycosis Fungoides; Sezary Syndrome

Interventions

Alefacept

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphadenopathy

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Results Point of Contact

• Title: Thomas E. Witzig, M.D.
• Organization: Mayo Clinic

witzig.thomas@mayo.edu

Study Officials

• Thomas E. Witzig, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 22, 2007
• Study Start: March 1, 2006
• Primary Completion: August 24, 2010
• Study Completion: July 25, 2019
• Last Updated: August 13, 2019
• Results First Posted: October 2, 2017

Record last verified: 2016-03

Locations

US (3)