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A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00337987
First received: June 15, 2006
Last updated: June 5, 2009
Last verified: June 2009
  Purpose

The standard treatment for PTCL is CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy. This study is attempting to determine whether adding other treatments to CHOP therapy will improve the chance of the disease going into remission or staying in remission. Because other drugs for T-cell lymphoma have not yet been given with CHOP, this study is looking at combining CHOP with ONTAK. ONTAK has been FDA approved for treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the surface of the tumor cells and killing the cell without causing damage to other types of cells in the body. Studies have shown that ONTAK has helped patients with PTCL who have failed chemotherapy.


Condition Intervention Phase
Peripheral T-Cell Lymphoma
Drug: Ontak
Drug: CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Phase II Study to Determine the Safety of the Combination of ONTAK (DAB389IL-2), an Interleukin-2 Fusion Toxin, in Combination With CHOP in Peripheral T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • safety and tolerability of the combination of ONTAK® (denileukin diftitox) and CHOP in newly diagnosed PTCL patients who are deemed candidates for chemotherapy by the investigators. [ Time Frame: upon completion of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to evaluate the response rate and time to treatment failure with Ontak administered in combination with CHOP [ Time Frame: upon completion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2005
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ontak
    ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia
    Other Name: DAB 389 IL-2
    Drug: CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy
    ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia
  Eligibility

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

Inclusion Criteria:

  • Pathological diagnosis of peripheral T-cell lymphoma of one of following histologies as per the REAL classification: peripheral T-cell lymphoma (unspecified), anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma.
  • Treatment naive except for prior radiation or a single cycle of CHOP.
  • Patients must have at least one clear-cut bidimensionally measurable site by physical exam and/or computed tomography. Baseline measurements of measurable sites and evaluation of evaluable disease must be obtained within 4 weeks prior to registration to this study.
  • Prior radiation therapy for localized disease is allowed as long as the irradiated area is not at the mediastinal area or at the only site of measurable disease. Therapy must be completed at least 4 weeks before the enrollment in study.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Age > 18 years old.
  • Adequate bone marrow reserve, indicated by absolute neutrophil count (ANC) ≥ 1000/mm³, platelets ≥50,000/mm³(25,000/mm³ if thrombocytopenia secondary to bone marrow involvement by lymphoma), and hemoglobin ≥8 g/dL. These values must be obtained within 2 weeks before protocol entry.
  • Adequate liver function, indicated by bilirubin ≤1.5 times the upper limit of normal (ULN), alanine transaminase (ALT) ≤2 times the ULN or aspartate transaminase (AST) ≤2.0 times the ULN and albumin > 3.0 g/dl.
  • Adequate renal function, indicated by serum creatinine ≤2.5 mg/dL. Laboratory values must be obtained within 2 weeks before study entry.
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
  • Able to give informed consent.

Exclusion Criteria:

  • Patients with diagnosis of Mycosis Fungoides or Sezary Syndrome
  • Patients with active Hepatitis B or Hepatitis C infection.
  • Patients with known HIV infection are excluded. These patients are excluded because the potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy. HIV testing is not required.
  • Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved and any continuing treatment is given on an outpatient basis.
  • Patients with previous anthracycline therapy (cumulative dose of > 100 mg/m2).
  • Patients with Left Ventricular Ejection Fraction (LVEF) < 50%.
  • Patients who are pregnant or breast-feeding. These patients are excluded because the effects of this treatment on the fetus and young children are unknown.
  • Prior invasive malignancies within past 5 years.
  • Allergic to or history of allergy to diphtheria toxin or IL-2.
  • Preexisting severe cardiovascular disease (e.g. CHF, Severe CAD, cardiomyopathy, MI within past 3 months, arrhythmia) requiring ongoing treatment.
  • Ongoing antineoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within past 30 days.
  • Patients with deep vein thrombosis within 3 months.
  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: NCT00337987

Contacts
Contact: Noelle Sowers, R.N. 203-785-2442 noelle.sowers@yale.edu
Contact: Donna LaCivita 203-737-2579 donna.lacivita@yale.edu

Locations
United States, Connecticut
Yale Comprehensive Cancer Center at Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Eisai Inc.
Investigators
Principal Investigator: Francine Foss, M.D. Yale University
  More Information

No publications provided

Responsible Party: Francine Foss, M.D., Principal Investigator, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00337987     History of Changes
Other Study ID Numbers: 0507000369
Study First Received: June 15, 2006
Last Updated: June 5, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Denileukin diftitox
Prednisone
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on November 27, 2014