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

First listed
Oct 17, 2007
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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