Know Cancer

or
forgot password

An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease


Phase 2
18 Years
N/A
Not Enrolling
Both
Hodgkin's Disease

Thank you

Trial Information

An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease


Secondary objectives include:

- to characterize progression-free survival

- to characterize time to progression

- to determine response duration

- to characterize the effect of study drug on health-related quality of life

- to explore the correlation of positron emission tomography (PET) scan results with
objective responses observed with conventional imaging in this patient population

- to characterize the immunogenicity response of MDX-060

- to characterize the safety of MDX-060, and

- to characterize the pharmacokinetic profile of MDX-060


Inclusion Criteria:



- Diagnosis of Hodgkin's disease [HD] (excluding HIV-associated HD)

- Patients must have read, understood, and provided written informed consent and Health
Insurance Portability and Accountability Act (HIPAA) authorization after the nature
of the study has been fully explained

- Patients must have failed or relapsed following second line (i.e., salvage)
chemotherapy or relapsed or failed following autologous stem cell transplant

- ECOG Performance Status of 0-2

- Patients must have bi-measurable disease

- At least 4 weeks since the last chemotherapy or radiation therapy with clinical
evidence of recovery from any toxicity associated with such treatment

- Life expectancy 12 weeks or greater

- Screening laboratory values must be met

- Patients on corticosteroids must be tapered off the medication 2 weeks prior to study
drug administration and remain off corticosteroids until study completion.

Exclusion Criteria:

- Previous treatment with any anti-CD30 antibody

- History of allogeneic transplant

- Any tumor lesion 10cm 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 active or chronic infection

- Apparent active or latent tuberculosis (TB) infection

- Patients who are pregnant or nursing

- Any underlying medical condition which, in the investigator's opinion, will make the
administration of the study drug hazardous or obscure the interpretation of adverse
events

- Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics,
or radiation therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

Day 50/57

Safety Issue:

No

Principal Investigator

Medarex Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Medarex

Authority:

United States: Food and Drug Administration

Study ID:

MDX060-05/05E

NCT ID:

NCT00284804

Start Date:

November 2005

Completion Date:

October 2009

Related Keywords:

  • Hodgkin's Disease
  • relapsed or refractory Hodgkin's Disease
  • Hodgkin Disease

Name

Location

Mayo ClinicRochester, Minnesota  55905
Mount Sinai School of MedicineNew York, New York  10029
Rush Cancer InstituteChicago, Illinois  60612
Henry Ford Health SystemDetroit, Michigan  48202
Roswell Park Cancer CenterBuffalo, New York  14263
Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506
California Oncology of the Central ValleyFresno, California  93710
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Nevada Cancer InstituteLas Vegas, Nevada  89135
City of Hope, National Medical CenterDuarte, California  91010
University of California, San Diego/Moores UCSD Cancer CenterLaJolla, California  92093-0698
H. Lee Moffitt Cancer & Research InstituteTampa, Florida  33612
St. Francis Hospital CenterBeech Grove, Indiana  46107
American Health Network of IndianaIndianapolis, Indiana  46237
Division of Hematology/Oncology, Tufts-New England Medical CenterBoston, Massachusetts  02111
Carolina BioOncology Institute, PLLCHuntersville, North Carolina  28078
M.D. Anderson Cancer Center, The University of TexasHouston, Texas  77030