Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma

Sponsor
HiberCell, Inc.
Study ID
NCT00545545
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Progressive Colorectal Carcinoma
  • Recurrent Colorectal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Imprime PGG 2 mg/kg — BIOLOGICAL
    Infusion of 2mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.
  • Imprime PGG 4 mg/kg — BIOLOGICAL
    Infusion of 4mg/kg on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.
  • Cetuximab — BIOLOGICAL
    Infusion 400 mg/m2 over 2 hours on Day 1, then 250 mg/m2 over 1 hour on Days 8, 15, 22, 29, and 36 of each 6-week treatment cycle;
  • Irinotecan — DRUG
    Infusion 125 mg/m2 i.v. over 1.5 hours on Days 1, 8, 15, and 22 of each 6-week treatment cycle
  • Imprime PGG 6mg/kg — BIOLOGICAL
    Infusion of 6mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops.

Study Details

Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.

Key Dates

Start date
Oct 31, 2007
Status verified
Mar 2025
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Imprime PGG 2mg/kg+Cetuximab+Irinotecan
    Treatment Arm 1 2.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
  • Experimental: Imprime PGG 4mg/kg+Cetuximab+Irinotecan
    Treatment Arm 1 4.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
  • Experimental: Imprime PGG 6mg/kg+Cetuximab+Irinotecan
    Treatment Arm 1 6.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan.
  • Experimental: Imprime PGG 2mg/kg+Cetuximab
    Treatment Arm 2 2.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
  • Experimental: Imprime PGG 4mg/kg+Cetuximab
    Treatment Arm 2 4.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.
  • Experimental: Imprime PGG 6mg/kg+Cetuximab
    Treatment Arm 2 6.0 mg/kg Imprime PGG administered weekly with concomitant cetuximab.

Primary Outcome Measure

Safety and Maximum Tolerated Dosage of Imprime PGG When Used in Combination With Cetuximab With or Without Irinotecan Therapy [ Time Frame: From the date of the first dose of study drug to disease progression or until development of a drug toxicity that precludes further protocol treatment, up to 15 months ]

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