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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I do not have a matching family donor for my transplant.
Select...
I have been diagnosed with a serious blood, immune, or metabolic disorder.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of the incidence of engraftment with historical data
Bone Transplantation
Impact of the use of umbilical cord blood as a source of hematopoietic stem cells
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
~1000
Busulfan
FDA approved
Fludarabine
FDA approved
Methylprednisolone
FDA approved
radiation therapy
1994
Completed Phase 3
~13390
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,797 Total Patients Enrolled
9 Trials studying Leukemia
79 Patients Enrolled for Leukemia
Kenneth G. Lucas, MDStudy ChairMilton S. Hershey Medical Center
9 Previous Clinical Trials
82 Total Patients Enrolled
1 Trials studying Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Not applicable.I do not have a matching family donor for my transplant.I have been diagnosed with a serious blood, immune, or metabolic disorder.My cord blood donor matches my HLA type or has up to 3 mismatches.I am 21 years old or younger.
Research Study Groups:
This trial has the following groups:- Group 1: Regimen A
- Group 2: Regimen B (patients who do not receive TBI)
- Group 3: Regimen C (patients with Fanconi's anemia/related disorders)
- Group 4: Regimen D
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions can cyclophosphamide be employed to manage?
"The preferred treatment for leukemia is usually cyclophosphamide, with its efficacy also being demonstrated in patients affected by ophthalmia, sympathetic nerve dysfunction, scalp structure disorders and different types of lung cancer."
Answered by AI
What is the upper limit of participants for this research program?
"At the moment, this trial is not currently seeking out new participants. It was initially published on September 1st 2003 and last updated January 9th 2014. For those searching for other trials, there are presently 4652 clinical studies recruiting patients with leukemia and 1070 recruitment opportunities related to cyclophosphamide therapy."
Answered by AI
Has cyclophosphamide been tested in a laboratory setting previously?
"Currently, 1070 clinical studies are underway on cyclophosphamide with 199 of them now in Phase 3. Over 33,000 medical centres worldwide have been designated to undertake these experiments, though most of the trials occur near Philadelphia, Pennsylvania."
Answered by AI
Is this investigation currently recruiting participants?
"At present, this clinical trial is not actively seeking volunteers. The original posting of the study was on September 1st 2003 with its most recent update being January 9th 2014. However, should you be curious about other trials related to leukemia and cyclophosphamide there are currently 4652 and 1070 respectively which require patients."
Answered by AI
How reliable is cyclophosphamide in protecting users from harm?
"Although there is limited clinical trial data supporting the efficacy of cyclophosphamide, it still received a rating of 2 due to existing safety information."
Answered by AI
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