Tacrolimus for Metastatic Solid Tumors

Phase-Based Progress Estimates
Johns Hopkins All Children's Hospital, Saint Petersburg, FLMetastatic Solid TumorsTacrolimus - Drug
1 - 50
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new, less intense chemotherapy treatment followed by a bone marrow transplant from a donor with a partial match, and then lower doses of immunosuppressive drugs.

Eligible Conditions
  • Refractory and/or Relapsed Metastatic Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: up to 2 years

0-180 days
To document the incidence of significant viral, bacterial and fungal infections
1 year
Event-free survival at 1 year
Overall survival at 1 year
progression-free survival at 1 year
Graft-vs-Host Disease
30-180 days
Document toxicities
30days-180 days
To compare the tumor microenvironment, circulating tumor cells, and expression of MHC antigens as well as tumor specific antigens pre- and post BMT
6 months
Event-free survival at 6 months
Overall survival at 6 months
progression-free survival at 6 months
75days -1year
chronic GVHD
day 60
up to 120 Days
Safety of Shortened duration of tacrolimus as assessed by number of participants with NRM and Grade III-IV acute GVHD at Day 120
up to 2 years
Non-Relapse Mortality

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Trial Design

1 Treatment Group

Reduced intensity conditioning
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Tacrolimus · No Placebo Group · Phase 2

Reduced intensity conditioningExperimental Group · 5 Interventions: Tacrolimus, low dose total body irradiation, Melphalan, Cyclophosphamide, Fludarabine · Intervention Types: Drug, Radiation, Drug, Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
538 Previous Clinical Trials
31,024 Total Patients Enrolled
Heather Symons, MD, MHSPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
35 Total Patients Enrolled

Eligibility Criteria

Age 1 - 50 · All Participants · 14 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 1 and 50 years old.

Frequently Asked Questions

Which type of patient would be ideal for this clinical trial?

"To participate in this study, patients must have cancer and be between the ages of 1 year old to 50 years old. Currently, the clinical trial is looking for 60 total patients." - Anonymous Online Contributor

Unverified Answer

How many people will be given the chance to participate in this clinical trial?

"Yes, according to the most recent update on clinicaltrials.gov, this trial is still looking for patients. The study was first posted almost 9 years ago on March 27th, 2013 and is seeking a total of 60 participants at 5 different locations." - Anonymous Online Contributor

Unverified Answer

Is the age limit for this experiment set at 70 years or below?

"This particular clinical trial requires that potential participants are aged between 1 year and 50 years old." - Anonymous Online Contributor

Unverified Answer

What is the standard function of Tacrolimus?

"Tacrolimus is an immunosuppressant medication that can be used to manage dermatitis, atopic conditions, multiple sclerosis, and acute myelocytic leukemia." - Anonymous Online Contributor

Unverified Answer

Where are patients able to participate in this trial?

"At the moment, investigators are looking for volunteers at 5 different study sites. If you live near Valhalla, Charlotte or Baltimore, it might be easier for you to participate because travel would be minimal." - Anonymous Online Contributor

Unverified Answer

Are there any more open slots for this research study?

"The listed information on clinicaltrials.gov suggests that this study is looking for more participants. The original posting was on March 27th, 2013 with the most recent edit being on August 12th, 2022." - Anonymous Online Contributor

Unverified Answer

When did the FDA approve the use of Tacrolimus?

"There is some data indicating that Tacrolimus is safe, but none yet supporting that it effective. Consequently, it received a score of 2." - Anonymous Online Contributor

Unverified Answer

What other scientific investigations have utilized Tacrolimus?

"At the moment, there are 1065 separate clinical trials researching tacrolimus. Out of those, 190 are in Phase 3. Most of the tacrolimus trials are based out of Philadelphia, Pennsylvania; however, 30089 different locations worldwide are running some form of trial for this medication." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.