Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:September 2012
End Date:March 2019

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A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer.

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.


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.
We found this trial at
7
sites
Goshen, Indiana 46526
Principal Investigator: Alexander Starodub, MD
Phone: 574-364-2439
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Jordan Berlin, MD
Phone: 800-811-8480
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
Principal Investigator: Christopher\ Lieu, MD
Phone: 720-848-0600
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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Columbus, Ohio 43210
Principal Investigator: RICHARD GOLDBERG, MD
Phone: 614-293-3657
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Columbus, OH
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Newark, Delaware 19718
Principal Investigator: Michael Guarino, MD
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Newark, DE
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Philadelphia, Pennsylvania 19111
Principal Investigator: Efrat Dotan, MD
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Philadelphia, PA
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Santa Monica, California 90404
Principal Investigator: JOEL HECHT, MD
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Santa Monica, CA
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