Status:
COMPLETED
Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Colon Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test...
Detailed Description
Background: * Resections to remove tumors in the liver, bile ducts and pancreas are rarely curative, and patients frequently succumb to disease recurrence in the ensuing months to year(s) after the o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects must have histologically or cytologically confirmed diagnoses of adenocarcinoma in one of the following scenarios:
- Primary tumors of the pancreas
- Primary tumors of the bile duct and ampulla
- Metastatic colorectal cancers to the liver
- Subjects must have disease resectable with a standard pancreatectomy (pancreaticoduodenectomy or distal pancreatectomy) or liver resection.
- Subjects may have received prior therapy, including neoadjuvant regimens.
- Subjects must have serum Carbohydrate antigen 19-9 (CA 19-9) elevations greater than the upper limit of normal but less than 2500 U/mL.
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Subjects must have adequate organ and marrow function as defined below:
- leukocytes \>3,000/mcL
- absolute neutrophil count \>1,500/mcL
- platelets \>90,000/mcL
- For subjects with Periampullary cancers that require a pancreaticoduodenectomy for complete tumor extirpation:
- total bilirubin \<10 upper limit of normal (ULN)\*
- Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamate-pyruvate transaminase (SGPT) \<5 X institutional upper limit of normal
- creatinine \<1.5X institutional upper limit of normal
- Subjects with periampullary cancers typically present with biliary obstruction resulting in significant abnormalities in liver function tests that do not reflect liver dysfunction. These values normalize after tumor removal. They can be normalized pre-operatively with biliary stenting, but several large studies have demonstrated an increase in infectious complications with drainage. As such, a practice standard has been to avoid stenting until bilirubin level rises above 10 X ULN.
- For subjects with liver tumors (cholangiocarcinoma or metastatic colorectal cancer) requiring a hepatectomy for complete tumor extirpation:
- total bilirubin \<2.5 X institutional upper limit of normal\*
- AST(SGOT)/ALT(SGPT) \<5 X institutional upper limit of normal\*
- creatinine \<1.5X institutional upper limit of normal
- Liver abnormalities in this range are consistent with parenchymal destruction from the tumor.
- For subjects with pancreas tumors that require a distal pancreatectomy for extirpation:
- total bilirubin \<1.5 X institutional upper limit of normal\*
- AST(SGOT)/ALT(SGPT) \<2 X institutional upper limit of normal\*
- creatinine \<1.5X institutional upper limit of normal
- Liver abnormalities in this range are consistent with pancreas cancer destruction from the tumor.
- The effects of MVT-5873 (HuMab-5B1) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 3 months after completion of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors.
- EXCLUSION CRITERIA:
- Presence of disease outside the confines of a standard operation for subjects with periampullary cancers (pancreatic and cholangiocarcinoma).
- Presence of disease outside the liver for subjects with intrahepatic/hilar cholangiocarcinoma or metastatic colorectal cancer, other than a primary tumor for subjects with metastatic colorectal cancer.
- Subjects who are receiving any other investigational agents.
- Fewer than 28 days (or 5 half-lives for systemic agents, whichever is shorter) from the last day of prior anticancer therapy, including chemotherapy, hormonal, investigational, and or biological therapies and irradiation.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
- requirements.
- Active concurrent malignancies within the last five years other than the primary tumor
- in subjects with metastatic colorectal cancer, basal or squamous cell skin carcinoma or non- medullary thyroid carcinoma.
- Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of the MVT-5873. Because there is an unknown but potential
- Subjects with active, Hepatitis B or C infection because of the potential for increased liver toxicity given the damaging effects of the virus.
- Allergic to chimeric, humanized or human antibodies.
- Received live vaccine within 4 weeks prior to first date of study intervention.
- Infection requiring hospitalization or herpes zoster treatment within 2 weeks prior to the first date of study intervention.
- Long-term infectious diseases (tuberculosis, fungal infections) active within 2 years prior to the first date of study intervention.
Exclusion
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03801915
Start Date
November 13 2019
End Date
May 27 2022
Last Update
March 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892