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

This study has been completed.
Sponsor:
Information provided by:
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00729053
First received: August 1, 2008
Last updated: January 8, 2009
Last verified: January 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Dr. Alice Bexon, Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00729053     History of Changes
Other Study ID Numbers: 2055-003
Study First Received: August 1, 2008
Last Updated: January 8, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014