Phase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma

NCT ID: NCT02118064

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31

Brief Summary

This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in patients with refractory colon cancer who had been previously treated with an Irinotecan-based chemotherapy.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G17DT-Irinotecan

500µg dose of G17DT intramuscular injection in combination with 125 mg/m\^2 intravenous infusion of Irinotecan over 90 minutes.

Group Type: EXPERIMENTAL

G17DT-Irinotecan

Intervention Type: BIOLOGICAL

500µg dose of G17DT intramuscular injection in combination with 125 mg/m\^2 intravenous infusion of Irinotecan over 90 minutes.

Interventions

G17DT-Irinotecan

500µg dose of G17DT intramuscular injection in combination with 125 mg/m\^2 intravenous infusion of Irinotecan over 90 minutes.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Have histologically confirmed cancer of the colon or rectum or both and objective evidence of distant metastases
• Have measurable disease
• Have previously been treated with an irinotecan based chemotherapy
• Have progressive metastatic disease after an irinotecan containing chemotherapy regimen (alone or in combination) for metastatic colorectal cancer
• Be at least 18 years of age
• Have laboratory data as specified below:

• Aspartate aminotransferase (AST) and ALT less than 2.5 times upper limit of normal
• Bilirubin less than 1.5 mg/dL (SI units, 25.65 mol/L)
• Creatinine less than 1.5 mg/dL (SI units, 132 mol/L)
• White blood cell (WBC) count greater than 3,000/mm3
• Platelets greater than 100,000/mm3
• Hemoglobin more than 9.5 g/dL (SI units, 5.9 mol/L)
• International normalized ratio of prothrombin time less than 1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits
• Have a life expectancy of at least 3 months
• Have a KPS score of 70 or greater
• Use contraceptive methods, if sexually active
• Have the ability to understand the requirements of the study, to provide written informed consent, agree to abide by the study restrictions, and agree to return for the required assessments

Exclusion Criteria

• Be pregnant or nursing
• Have only symptomatic locally recurrent colorectal cancer
• Have had any active cancer in addition to metastatic colorectal cancer within the last 5 years except curatively treated nonmelanomatous skin cancer
• Have received any prior anticancer immunotherapy
• Have central nervous system metastasis, whether treated or not
• Have bone metastases as sole manifestation of metastatic colorectal cancer
• Have received chemotherapy within the previous 21 days
• Have had major surgery within 21 days
• Have immunodeficiency (primary or acquired)
• Have undergone bone marrow transplantation within the last year
• Require chronic administration of corticosteroids; inhaled corticosteroids for asthma and chronic obstructive pulmonary disease are allowed
• Use in the past 30 days or concomitant use of immunosuppressants, including systemic (i.e., oral or injected) corticosteroids
• Have participated in any clinical trial involving conventional or investigational drugs or devices within 21 days before G17DT irinotecan administration
• Have contraindication to irinotecan based therapy
• Have hypersensitivity to diphtheria toxoid
• Use in the past 14 days or chronic concomitant use of proton pump inhibitors
• Have uncontrolled serious cardiovascular or metabolic disease or any other uncontrolled serious medical or psychiatric illness
• Have any condition that is likely to detrimentally affect regular follow up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Advances Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CC6

Identifier Type: -

Identifier Source: org_study_id