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Chemotherapy

Reduced Intensity BMT for Solid Cancer

Phase 2

Recruiting

Led By Heather Symons, MD, MHS

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Neuroblastoma or ganglioneuroblastoma

Patients must be recovered from the acute toxicities of any prior chemo/radio/immunotherapy or BMT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

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.

Who is the study for?

This trial is for patients with high-risk solid tumors who have a low chance of survival and haven't responded well to standard treatments. They need normal kidney function, decent heart function, and good overall health status. Participants must have a related donor who's partially genetically matched for bone marrow donation.Check my eligibility

What is being tested?

The study tests whether reduced intensity chemotherapy combined with haploidentical bone marrow transplant, post-transplant cyclophosphamide, and shortened tacrolimus treatment is safe and effective in patients with very high-risk solid tumors.See study design

What are the potential side effects?

Possible side effects include reactions to the drugs like nausea, hair loss, mouth sores from chemotherapy; increased risk of infections; potential organ damage due to intense drug therapy; and complications from the bone marrow transplant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with neuroblastoma or ganglioneuroblastoma.

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I have recovered from the side effects of my previous cancer treatments.

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My donor and I match in at least one gene at five specific genetic locations.

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My liver function tests are within the required range.

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My kidney function is normal or meets the minimum required level.

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My cancer did not respond to initial standard chemotherapy treatments.

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I have high-risk disease and cannot undergo intense treatment due to my organ function.

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My condition is stage 4 rhabdomyosarcoma.

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My cancer is metastatic Ewing Sarcoma.

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My osteosarcoma has spread beyond my lungs or to areas in my lungs that cannot be surgically removed.

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My lung function tests are above 50% of what's expected, or my oxygen levels are above 92% without assistance.

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I am mostly able to carry out daily activities.

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My diagnosis is high risk with an expected survival rate of less than 10%.

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I have a family member who is a match for a bone marrow donation.

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My donor and I share at least one HLA haplotype.

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My heart's pumping ability is within the required range.

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I have been diagnosed with desmoplastic small round cell tumor.

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My cancer did not respond well to my first chemotherapy treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of Shortened duration of tacrolimus as assessed by number of participants with NRM and Grade III-IV acute GVHD at Day 120

Secondary outcome measures

Event-free survival at 1 year

Event-free survival at 6 months

Non-Relapse Mortality

+7 more

Other outcome measures

Document toxicities

To compare the tumor microenvironment, circulating tumor cells, and expression of MHC antigens as well as tumor specific antigens pre- and post BMT

To document the incidence of significant viral, bacterial and fungal infections

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Reduced intensity conditioningExperimental Treatment5 Interventions

Fludarabine IV infusion over 30 minutes on D-7 to D-3. The dose will be 30 mg/m2/dose (adjusted for renal function). Melphalan: IV infusion over 30-60 minutes, depending on volume, on D-2. The dose will be 100mg/m2.Total body irradiation: 200 cGy AP/PA with 4MV or 6MV photons at 8 12 cGy/min at the point of prescription (average separation of measurements at mediastinum, abdomen, and hips) will be administered in a single fraction on day -1. Bone Marrow will be harvested and infused on day 0. Post-transplantation Cyclophosphamide 50mg/kg will be given on D+3 post-transplant (within 60-72 hr of marrow infusion) and on D+4 post-transplant. Tacrolimus begins on Day 5, at least 24 hours after completion of posttransplantation Cy at 0.015mg/kg IBW/dose IV over 3 hours every 12 hours. Mycophenolic acid mofetil (MMF) F will be given at a dose of 15 mg/kg PO TID (based upon actual body weight) with the maximum total daily dose not to exceed 3 grams (1 g PO TID).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

Melphalan

2008

Completed Phase 3

~1500

Tacrolimus

2011

Completed Phase 4

~4740

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,860 Total Patients Enrolled

Heather Symons, MD, MHSPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

35 Total Patients Enrolled

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01804634 — Phase 2

Solid Tumors Research Study Groups: Reduced intensity conditioning

Solid Tumors Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01804634 — Phase 2

Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01804634 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

2013. "Reduced Intensity Haploidentical BMT for High Risk Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01804634.

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