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Alkylating agents

Umbilical Cord Blood Transplant for Cancer

Phase 2

Waitlist Available

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

No other existing HLA-identical related donor available at the time of transplantation

Diagnosis of malignant or non-malignant disease including but not limited to specific conditions such as acute myeloid leukemia, acute lymphoblastic leukemia, Burkitt's lymphoma/leukemia, chronic myelogenous leukemia, juvenile myelomonocytic leukemia, advanced stage or relapsed lymphoma, neuroblastoma, Ewing's sarcoma, rhabdomyosarcoma, myelodysplastic syndromes, familial erythrophagocytic histiocytosis, histiocytosis unresponsive to medical management, inborn errors of metabolism, Langerhans cell histiocytosis unresponsive to medical management, immune deficiencies such as severe combined immune deficiency, Wiskott-Aldrich, hemoglobinopathies, severe aplastic anemia, Fanconi's anemia, metabolic storage diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 50 Other Conditions

No Placebo-Only Group

Summary

This trial is studying whether using stem cells from umbilical cord blood can help treat cancer or other diseases.

Who is the study for?

This trial is for young patients, age 21 or under, with certain cancers like leukemia and solid tumors, or non-malignant diseases such as Fanconi anemia. Participants must meet specific disease criteria detailed in the study's characteristics section.

What is being tested?

The trial is testing how well stem cells from umbilical cord blood can replace immune cells destroyed by cancer treatments. It involves chemotherapy drugs (cyclophosphamide, melphalan), radiation therapy, and other agents to prepare the body for transplantation.

What are the potential side effects?

Potential side effects include damage to organs from chemotherapy drugs and radiation, increased risk of infections due to weakened immunity, allergic reactions to medications used during transplant preparation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I do not have a matching family donor for my transplant.

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I have been diagnosed with a serious blood, immune, or metabolic disorder.

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I am 21 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 50 Other Conditions

This treatment demonstrated efficacy for 50 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Regimen DExperimental Treatment3 Interventions

Patients receive oral or IV busulfan 4 times daily on days -9 to -5, ATG IV over at least 6 hours on days -5 to -3, and cyclophosphamide IV over 30-60 minutes on days -5 to -2.

Group II: Regimen C (patients with Fanconi's anemia/related disorders)Experimental Treatment5 Interventions

Patients undergo TBI on day -6. Patients receive ATG IV over at least 6 hours and methylprednisolone IV on days -5 to -1 and fludarabine IV over 30 minutes and cyclophosphamide IV over 30-60 minutes on days -5 to -2.

Group III: Regimen B (patients who do not receive TBI)Experimental Treatment3 Interventions

Patients receive oral busulfan 4 times daily on days -8 to -5, and ATG IV over at least 6 hours and melphalan IV over 15-20 minutes on days -4 to -2.

Group IV: Regimen AExperimental Treatment3 Interventions

Patients undergo total body irradiation (TBI) two times daily on days -7 to -4. Patients receive cyclophosphamide IV over 30-60 minutes on days -3 and -2 and anti-thymocyte globulin (ATG) IV over at least 6 hours on days -3 to -1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

Melphalan

FDA approved

anti-thymocyte globulin

2005

Completed Phase 3

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