Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03435952
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Malignant Neoplasm of Breast
  • Malignant Neoplasms of Digestive Organs
  • Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System
  • Malignant Neoplasms of Female Genital Organs
  • Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites
  • Malignant Neoplasms of Independent (Primary) Multiple Sites
  • Malignant Neoplasms of Lip Oral Cavity and Pharynx
  • Malignant Neoplasms of Male Genital Organs
  • Malignant Neoplasms of Mesothelial and Soft Tissue
  • Malignant Neoplasms of Respiratory and Intrathoracic Organs
  • Malignant Neoplasms of Thyroid and Other Endocrine Glands
  • Malignant Neoplasms of Urinary Tract

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    200 mg by intravenous infusion starting on Day 0, and continuing every 3 weeks for up to 12 months.
  • Clostridium Novyi-NT — BIOLOGICAL
    Participants given a single dose of Clostridium Novyi-NT by intratumoral injection on Day 8. Clostridium Novyi-NT administered starting with Cohort 1 at a dose of 3 x 10\^4 spores followed by dose escalation.
  • Doxycycline — DRUG
    Starting on Day 15, participant takes Doxycycline by mouth 2 times a day for the rest of participant's life to lower the risk of further growth of Clostridium novyi-NT

Study Details

Some tumors are difficult to treat with chemotherapy or radiation. One of the reasons is that areas of the tumor do not have many blood vessels, which makes it difficult for drugs to reach those areas. One way that researchers have recently tried to overcome this problem is by injecting special kinds of bacteria into the tumors. These bacteria have been genetically changed to remove the chemicals that are poisonous to humans, but are still able to cause tumor cells to break down and die. The idea is that these bacteria may be able to assist chemotherapy drugs in fighting cancer. The goal of this clinical research study is to find the highest tolerable dose of one of these bacterial therapies (Clostridium novyi-NT spores) that can be given in combination with pembrolizumab to patients with advanced solid tumors. The safety of this drug will also be studied, as well as whether it can help to control the disease. This is an investigational study. Clostridium novyi-NT is not FDA approved or commercially available. It is currently being used for research purposes only. Pembrolizumab is FDA approved for the treatment of melanoma and different types of head and neck and non-small cell lung cancers. It is investigational to use these drugs in combination with each other in various types of advanced cancers. The study doctor can describe how the study drugs are designed to work. Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.

Key Dates

First listed
Feb 19, 2018
Start date
Jul 10, 2018
Status verified
Apr 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Clostridium novyi-NT
    Participants receive Pembrolizumab by vein over about 30 minutes on Day 0 and then every 3 weeks for up to 12 months. Clostridium novyi-NT injected into the tumor on Day 8. Starting on Day 15, participant takes Doxycycline by mouth 2 times a day for the rest of participant's life to lower the risk of further growth of Clostridium novyi-NT

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Intratumoral Injection of Clostridium Novyi-NT with Pembrolizumab [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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