Clinical trial NCT00729053: Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Official title: A Phase 2, Multi-Center, Randomized, Open-Label Study of Two Dose Levels of IMOxine® (IMO-2055 for Injection) in Patients With Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: renal
cell
renal carcinoma
metastatic
recurrent
treatment naive
Lead sponsor: Idera Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-06
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Multi-Center
* Randomized
* Open-Label Study of single agent IMO-2055
* Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)

Detailed description: This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly subcutaneous (SC) injections in two patient populations, treatment naïve or previously treated patients. Each dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed stage IV clear cell renal carcinoma with metastatic or locally recurrent disease that is not surgically resectable.
* At least one measurable lesion
* Adequate organ function
* Any prior treatment of renal cell cancer was concluded at least 4 weeks prior.
* If female and of childbearing potential, a negative serum pregnancy test performed and documented no more than 14 days before the first dose of study drug.

Exclusion Criteria:

* Known untreated central nervous system (CNS) metastasis
* Pre-existing autoimmune or antibody-mediated diseases
* Other significant medical disease.

Primary outcomes:
measure: Best Response by RECIST v1.0
timeFrame: From start of treatment every 8 weeks (every 2 cycles), 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity
timeFrame: From start of treatment through one month after the end of study visit (up to 28 weeks)
measure: Duration of Response by RECIST v1.0
timeFrame: Every 8 weeks (2 cycles) from first response to documented disease progression during treatment, 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.
measure: Overall Survival at 1 Year
timeFrame: From date of randomization until the date of progression or date of death from any cause, whichever came first, asses up to 1 year after the last dose of study drug.
measure: Time to Disease Progression.
timeFrame: Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University, Lombardi Cancer Center
state: District of Columbia
Study officials:
affiliation: Idera Pharmaceuticals
name: Alice Bexon, MD
role: STUDY_DIRECTOR
References: