MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

This study has been withdrawn prior to enrollment.
(sponsor decision)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00298467
First received: March 1, 2006
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease. There will be 3 phases of this study: Induction, Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as other testing. Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression. The purpose of this study is to determine objective response rate at Day 50 in patients with relapsed or refractory classic systemic ALCL or primary cutaneous ALCL treated with MDX-060. Other objectives will be evaluated.


Condition Intervention Phase
Lymphoma, Large-Cell
Drug: MDX-060
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Fixed-dose, Multicenter, Phase II Study of MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective response rate
  • progression free survival
  • response duration
  • Quality of Life
  • Immunogenicity
  • best objective response rate
  • safety

Estimated Enrollment: 45
Study Start Date: February 2006
Detailed Description:

This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease. There will be 3 phases of this study: Induction, Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as other testing. Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression.

The primary objective of the study is to determine the objective response rate (ORR) at Day 50 in patients with relapsed or refractory classic systemic anaplastic large cell lymphoma (csALCL) or primary cutaneous ALCL (pcALCL) treated with MDX-060. The ORR will be based on an adaption of the NCI Response Criteria for Non-Hodgkin's Lymphoma (NHL) for patients with csALCL and will be based on the Physician's Global Assessment (PGA) for patient with pcALCL.

Secondary objectives include 1) characterizing progression-free survival (PFS); 2) determining response duration (RD); 3) characterizing the effect of MDX-060 on health-related Quality of Life (QoL); 4) evaluating patients with pcALCL using an adaption of the NCI Response Criteria for NHL; 5) characterizing the immunogenicity of MDX-060; 6) characterizing the safety of MDX-060; and 7) determining the best objective response rate (BORR) during the Maintenance Phase of the study.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed informed consent
  • confirmed diagnosis of ALCL
  • patient with csALCL must be confirmed CD30+
  • patients with csALCL must have failed or relapsed following second line (i.e. salvage) chemotherapy or relapsed or failed following autologous stem cell transplant.
  • patients with pcALCL must have progressed after treatment with local radiation therapy or surgical excision or failed systemic therapy with a single agent or multi-agent regimen.
  • patients with pcALCL must be confirmed CD30+
  • ECOG performance of 0 to 2
  • at least 12 years of age
  • life expectancy 12 weeks or greater
  • must meet screening laboratory values
  • women must be post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing a reliable form of contraception. All women must have a negative pregnancy test.
  • men must agree to the use of male contraception for the duration of the study
  • patients on corticosteroids must be tapered off the medication 2 weeks prior to the first MDX-060 administration and remain off corticosteroids until day 365.

Exclusion Criteria:

  • previous treatment with any anti-CD30 antibody
  • history of allogenic transplantation
  • any tumor lesion 10 cm or greater in diameter
  • any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
  • any significant acter or chronic infection.
  • prior known serum positivity for HIV, hepatitis B or C as determined at screening.
  • treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) of study screening.
  • apparent active or latent tuberculosis infection (TB).
  • patients who are pregnant or nursing
  • any underlying medical condition which, in the investigator's opinion, will make the administration of MDX-060 hazardous or obscure the interpretation of adverse events.
  • concomitant chemotherapy, corticosteroids, investigational agents, other anti-ALCL biologics, or radiation therapy
  • patients with mycosis fungoides, or
  • patients with recurrent, self-healing papulonodular eruptions only or any other lymphoma other than ALCL.
  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: NCT00298467

Locations
United States, California
City of Hope, National Medical Center
Duarte, California, United States, 91010
California Oncology of the Central Valley
Fresno, California, United States, 93710
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
The Cancer Institute of New Jersey - Robert Wood Johnson Unv. Hosp.
New Brunswick, New Jersey, United States, 08901
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
United States, North Carolina
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
France
Centre Hospitalier Regional Unv. de Lille, Hopital Claude Huriez
Lille, France, 59037
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00298467     History of Changes
Other Study ID Numbers: MDX060-04
Study First Received: March 1, 2006
Last Updated: April 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
ALCL
csALCL
pcALCL
Lymphoma
Non-Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma
classic systemci Anaplastic Large Cell Lymphoma (csALCL)
primary cutaneous Anaplastic Large Cell Lymphoma (pcALCL)

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma
Lymphoma, Primary Cutaneous Anaplastic Large Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on October 19, 2014