Clinical trial NCT00656734: Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.
Official title: A Phase 1, Open-Label, Multicenter Dose-escalation, Multidose Study of MDX1411 Administered Every 14 Days in Subjects With Advanced or Recurrent Clear Cell Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Cancer
Keywords: Medarex Inc.
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-04-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).

Detailed description: Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of RCC with clear cell component
* Measurable disease
* Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy
* Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible
* At least 28 days since the last chemotherapy
* At least 28 days before the first dose of MDX 1411 since any major surgery
* ECOG performance status 0-2
* No known positivity for human immunodeficiency virus (HIV), Hep B or C

Exclusion Criteria:

* Previous treatment with any other anti-CD70 antibody
* Active infection requiring i.v systemic therapy within 28 days before first dose
* Evidence of bleeding diathesis or coagulopathy
* Active autoimmune disease requiring immunosuppressive therapy
* Known current drug or alcohol abuse
* Any underlying medical condition which will make the administration of MDX 1411 hazardous
* Psychiatric illness or social situation that would preclude study compliance

Primary outcomes:
measure: Determine the safety profile of MDX 1411
timeFrame: duration of study
measure: Determine the maximum tolerated dose of MDX 1411
timeFrame: duration of study
Secondary outcomes:
measure: Determine the best overall response rate (BORR)
timeFrame: Day 38-42 of each cycle
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: