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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

Must not have

Uncontrolled viral, bacterial, or fungal infections.

Women of childbearing potential who currently are pregnant (HCG+) or who are not practicing adequate contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled infections.

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I am a woman who could get pregnant and am not using effective birth control or am currently pregnant.

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I am older than 6 months.

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My donor has a KIR Haplotype B.

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My donor's blood type does not match mine, but a matching donor is available.

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

~1020

Melphalan

2008

Completed Phase 3

~1500

Tacrolimus

2011

Completed Phase 4

~4740

0 / 23Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,748 Previous Clinical Trials

40,959,341 Total Patients Enrolled

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

563 Previous Clinical Trials

33,264 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

~11 spots leftby Jan 2027

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