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

Brief Summary

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”

- Multi-Center

- Randomized

- Open-Label Study of single agent IMO-2055

- Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2008

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Drug: IMO-2055
    • immunostimulatory oligonucleotide

Arms, Groups and Cohorts in this Clinical Trial

  • 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
  • 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
  • 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
  • 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

Outcome Measures for this Clinical Trial

Primary 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
      Safety Issue?: No

Secondary Measures

  • To determine the safety of IMO-2055
    • Time Frame: all visits
      Safety Issue?: Yes
  • To determine the duration of response to IMO-2055
    • Time Frame: every 2 cycles
      Safety Issue?: No
  • To determine overall survival
    • Time Frame: every 2 cycles
      Safety Issue?: No
  • To determine the time to disease progression.
    • Time Frame: every 2 cycles
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Idera Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Dr. Alice Bexon, Idera Pharmaceuticals, Inc.
  • Overall Official(s)
    • Alice Bexon, MD, Study Director, Idera Pharmaceuticals

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00729053