Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMMU-130
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring metastatic colorectal cancer, colon cancer, rectal cancer, previously treated
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UCLA Jonsson Comprehensive Cancer Center
- University of Colorado Anschutz Medical Campus
- Helen F. Graham Cancer Center-Christiana Care
- IUHealth Goshen Center for Cancer Care
- The Ohio State University Comprehensive Cancer Center
- Fox Chase
- Vanderbilt-Ingram Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMMU-130
Arm Description
All patients receive IMMU-130 administered in 21-day treatment cycles consisting of once or twice weekly for 2 consecutive weeks followed by a 1-week rest period. Treatment can be continued in the absence of unacceptable toxicity for a period of up to 8 cycles until the first documentation of Progressive Disease by CT (physician discretion), but must terminate study treatment upon the second documentation of Progressive Disease.
Outcomes
Primary Outcome Measures
Evaluate the safety and tolerability of IMMU-130
Secondary Outcome Measures
Obtain information on efficacy
Efficacy will be evaluated from CT scans using RECIST criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01605318
Brief Title
Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
Official Title
A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No patients are enrolled in any studies conducted under this IND
Study Start Date
September 2012 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles, once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen. The study is being done to evaluate whether the study drug is safe and tolerable at different dose levels with these dosing schedules and to obtain preliminary information on its efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
Keywords
metastatic colorectal cancer, colon cancer, rectal cancer, previously treated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMMU-130
Arm Type
Experimental
Arm Description
All patients receive IMMU-130 administered in 21-day treatment cycles consisting of once or twice weekly for 2 consecutive weeks followed by a 1-week rest period. Treatment can be continued in the absence of unacceptable toxicity for a period of up to 8 cycles until the first documentation of Progressive Disease by CT (physician discretion), but must terminate study treatment upon the second documentation of Progressive Disease.
Intervention Type
Drug
Intervention Name(s)
IMMU-130
Other Intervention Name(s)
hMN14-SN38, Labetuzumab-SN38, Antibody-Drug Conjugate
Intervention Description
This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles, once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen.
Primary Outcome Measure Information:
Title
Evaluate the safety and tolerability of IMMU-130
Time Frame
Every 3 months
Secondary Outcome Measure Information:
Title
Obtain information on efficacy
Description
Efficacy will be evaluated from CT scans using RECIST criteria
Time Frame
During treatment and the changes at 4, 8 and 12 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Wegener
Organizational Affiliation
Gilead Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA Jonsson Comprehensive Cancer Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Helen F. Graham Cancer Center-Christiana Care
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
IUHealth Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Fox Chase
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20953556
Citation
Govindan SV, Goldenberg DM. New antibody conjugates in cancer therapy. ScientificWorldJournal. 2010 Oct 12;10:2070-89. doi: 10.1100/tsw.2010.191.
Results Reference
background
PubMed Identifier
19789330
Citation
Govindan SV, Cardillo TM, Moon SJ, Hansen HJ, Goldenberg DM. CEACAM5-targeted therapy of human colonic and pancreatic cancer xenografts with potent labetuzumab-SN-38 immunoconjugates. Clin Cancer Res. 2009 Oct 1;15(19):6052-61. doi: 10.1158/1078-0432.CCR-09-0586. Epub 2009 Sep 29.
Results Reference
background
PubMed Identifier
18939816
Citation
Moon SJ, Govindan SV, Cardillo TM, D'Souza CA, Hansen HJ, Goldenberg DM. Antibody conjugates of 7-ethyl-10-hydroxycamptothecin (SN-38) for targeted cancer chemotherapy. J Med Chem. 2008 Nov 13;51(21):6916-26. doi: 10.1021/jm800719t. Epub 2008 Oct 22.
Results Reference
background
PubMed Identifier
16029057
Citation
Govindan SV, Griffiths GL, Hansen HJ, Horak ID, Goldenberg DM. Cancer therapy with radiolabeled and drug/toxin-conjugated antibodies. Technol Cancer Res Treat. 2005 Aug;4(4):375-91. doi: 10.1177/153303460500400406.
Results Reference
background
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Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer
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