Clinical Trial VICCPHI1314
A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14- SN38, Antibody-Drug Conjugate) in Patients with Colorectal Cancer
- Protocol No. VICCPHI1314
- Open Date: 06/25/2013
- Staging: Phase I/II
- Age Group: Adults
- Scope: National
- Objective: To evaluate the safety and tolerability of repeated 21-day treatment cycles of IMMU-130 and to determine the maximum tolerated dose (MTD) for this dosing schedule when administered to patients with metastatic colorectal cancer who have failed at least one prior irinotecan-containing therapy.
- Disease Sites:
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01605318
- Secondary Protocol No: IMMU-130-02
Patients are asked to take part in this research study because they have colorectal cancer. Standard treatments for colorectal cancer may use forms of chemotherapy. In some cases, external radiation therapy may be used as well. These treatments may slow the cancer for some patients, but the cancer will continue to worsen for most patients. The study doctor is researching a new therapy product called IMMU-130. IMMU-130 is composed of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is a common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the immune system. They bind to substances that don-t belong in the body to prevent harm to the body. The antibody in this study was designed to bind to a marker located on colorectal cancer tumors. The antibody was originally made from mouse proteins, but was changed in the laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is safe. The purpose of this study is to test the safety of IMMU-130 at different dose levels. We want to find out what effects, good and/or bad, it has on patients and advanced colorectal cancer.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• Male or female patients, ≥ 18 years of age, able to understand and give written informed consent.
• Histologically or cytologically confirmed colorectal adenocarcinoma.
• Stage IV (metastatic) disease.
• Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer.
• Adequate performance status (ECOG 0 or 1). (Appendix 1)
• Expected survival > 6 months.
• CEA plasma levels > 5 ng/mL.
• Measurable disease by CT or MRI.
• At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities.
• At least 2 weeks beyond corticosteroids.
• Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
• Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
• Otherwise, all toxicity at study entry ≤ Grade 1 by NCI CTC v4.0.
• Women who are pregnant or lactating.
• Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
• Patients with Gilbert's disease or known CNS metastatic disease.
• Patients with CEA plasma levels > 1000 ng/mL are excluded during dose escalation, but may be included after the MTD is determined.
• Presence of bulky disease (defined as any single mass > 10 cm in its greatest dimension).
• Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
• Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
• Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
• Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
• Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
• Infection requiring intravenous antibiotic use within 1 week.
• Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.