Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma - Full Text View

Purpose

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

Condition	Intervention	Phase
Renal Cell Carcinoma	Drug: IMO-2055	Phase II

MedlinePlus related topics:

Kidney Cancer

ChemIDplus related topics:

Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Amplivax

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Idera Pharmaceuticals, Inc.:

Primary Outcome Measures:

To determine the best overall objective response (Complete Response [CR] + Partial Response [PR]), by RECIST in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055. [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety of IMO-2055 [ Time Frame: all visits ] [ Designated as safety issue: Yes ]
To determine the duration of response to IMO-2055 [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]
To determine overall survival [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]
To determine the time to disease progression. [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	224
Study Start Date:	June 2004
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Previous treatment, 0.16mg/kg: Active Comparator Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg	Drug: IMO-2055 immunostimulatory oligonucleotide
Previous treatment, 0.64mg/kg: Active Comparator Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg	Drug: IMO-2055 immunostimulatory oligonucleotide
Treatment Naive, 0.16mg/kg: Active Comparator Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg	Drug: IMO-2055 immunostimulatory oligonucleotide
Treatment Naive, 0.64mg/kg: Active Comparator Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg	Drug: IMO-2055 immunostimulatory oligonucleotide

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

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729053

Locations


United States, District of Columbia
	Georgetown University, Lombardi Cancer Center
	Washington, District of Columbia, United States, 20007

Sponsors and Collaborators

Idera Pharmaceuticals, Inc.

Investigators


Study Director:	Alice Bexon, MD	Idera Pharmaceuticals

More Information

Sponsor Website This link exits the ClinicalTrials.gov site

Responsible Party:	Idera Pharmaceuticals, Inc. ( Dr. Alice Bexon )
Study ID Numbers:	2055-003
First Received:	August 1, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00729053
Health Authority:	United States: Food and Drug Administration

Keywords provided by Idera Pharmaceuticals, Inc.:

renal

cell

renal carcinoma

metastatic

recurrent

treatment naive

Study placed in the following topic categories:

Leucovorin

Urogenital Neoplasms

Renal cancer

Urologic Neoplasms

Kidney cancer

Recurrence

Carcinoma

Urologic Diseases

Kidney Neoplasms

Carcinoma, Renal Cell

Kidney Diseases

Adenocarcinoma

Clear cell renal cell carcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Idera Pharmaceuticals, Inc.
Information provided by:	Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00729053