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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729053
First Posted: August 6, 2008
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Idera Pharmaceuticals, Inc.
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • To determine the safety of IMO-2055 [ Time Frame: all visits ]
  • To determine the duration of response to IMO-2055 [ Time Frame: every 2 cycles ]
  • To determine overall survival [ Time Frame: every 2 cycles ]
  • To determine the time to disease progression. [ Time Frame: every 2 cycles ]

Estimated Enrollment: 224
Study Start Date: June 2004
Study Completion Date: November 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Previous treatment, 0.16mg/kg
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
Active Comparator: Previous treatment, 0.64mg/kg
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
Active Comparator: Treatment Naive, 0.16mg/kg
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
Active Comparator: Treatment Naive, 0.64mg/kg
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Dr. Alice Bexon, Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00729053     History of Changes
Other Study ID Numbers: 2055-003
First Submitted: August 1, 2008
First Posted: August 6, 2008
Last Update Posted: November 13, 2017
Last Verified: January 2009

Keywords provided by Idera Pharmaceuticals, Inc.:
renal
cell
renal carcinoma
metastatic
recurrent
treatment naive

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases