VM110 in Detection of Microscopic Tumors: A Phase I Study

NCT03286062 | Terminated Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: GYN-105
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

A laproscopic imaging tecgnology that uses a synthetic agent to detect ovarian and pancreatic cancers at an early stage so that patients can get treatment early and prevent the disease from advancing to late stage leading to fatality or recurrence.

Conditions

Ovarian Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of VM110 related toxicity assessed by NCI CTCAE criteria 4.03

  Patients would be monitored for severity of adverse events due to VM110 based on NCI CTCAE criteria 4.03

  3-62 weeks

Study Arms (1)

VM110

EXPERIMENTAL

Escalating dose of agent VM110 given to patients to visualize occult cancer with laproscopic infra red detect

Combination Product: Agent VM110 and laproscopic infra-red probe

Interventions

Agent VM110 and laproscopic infra-red probe COMBINATION_PRODUCT

Patients with evidence of persistent or recurrent ovarian/ pancreatic cancer would be injected with escalating dose of VM110 24 hr prior to laproscopic surgery to collect biopsy sample in white light and by visualizing the cancerous mass using the laproscopic infra red probe

VM110

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known or suspected pancreatic or ovarian carcinoma who will be undergoing clinically appropriate laparoscopic evaluation or treatment. Patients will not undergo laparoscopy solely for the purpose of participation in this trial.
• Patients must have evidence of disease either through elevation of tumor markers or radiologic evidence of disease
• Patient may be male or female and of any race / ethnicity.
• Participation in this trial will not significantly alter pre-surgical, surgical or post-surgical care
• ECOG PS of 0-1
• Patients should be free of active infection requiring antibiotics
• Any therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
• Patients must have adequate:
• Renal function: serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
• Hepatic function: Total bilirubin less than or equal to 1.5 x ULN , SGOT and alkaline phosphatase less than or equal to 2.5 x ULN
• PTT (partial thromboplastin time) ≤ 1x ULN and INR ≤ 1.5 x ULN.
• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after. Highly effective contraception methods include combination of any two of the following:
• Use of oral, injected or implanted hormonal methods of contraception, or;
• Placement of an intrauterine device (IUD) or intrauterine system (IUS);
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;

You may not qualify if:

• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
• Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin used for catheter-related thrombosis prophylaxis).
• Prior history of hypersensitivity to Pegylated liposomal doxorubicin or ICG allergy. Caution should be taken if prior ICG allergy is noted.
• Pregnant or nursing (lactating) women
• History of congestive cardiac failure or an EKG suggesting significant conduction defect, or myocardial ischemia, or active psychiatric disease requiring treatment that would interfere with the understanding or conduct of the study.
• Subject has previously received VM110, or any other investigational product in the past thirty days.
• Inadequate tumor sites or volume to allow for biopsy per standard of care.
• Patients with psychiatric or other conditions rendering them incapable of participating in informed consent or the requirements of this protocol or other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases

Study Officials

• Gina Martina-Smaldone, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi dose Phase I study with injection of VM110 at 5 dose levels

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 18, 2017
• Study Start: October 12, 2017
• Primary Completion: July 10, 2019
• Study Completion: April 3, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)