CompletedPhase 1/2

Combination Chemotherapy and Total-Body Irradiation Before Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer, Metastatic Breast Cancer, or Kidney Cancer

148 participantsStarted 2000-06

Plain-language summary

RATIONALE: Giving low doses of chemotherapy and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of giving combination chemotherapy together with total-body irradiation before donor umbilical cord blood transplant and to see how well they work in treating patients with advanced hematologic cancer, metastatic breast cancer, or kidney cancer.

Who can participate

Age range

69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Acute myeloid leukemia (AML), meeting 1 of the following criteria: * In first complete remission (CR1) by morphology AND at high risk, as evidenced by 1 of the following: * AML secondary to myelodysplastic syndromes (MDS) * High-risk cytogenetics, such as those associated with MDS or complex karyotype * More than 2 courses of therap were required to obtain a CR * In second or greater CR by morphology * In morphologic relapse or persistent disease, defined as \> 5% blasts in normocellular bone marrow OR any percentage of blasts if blasts have unique morphologic markers (e.g., auer rods) * In cytogenetic relapse (without morphologic relapse) * Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria: * In CR1 by morphology AND at high risk, as evidenced by 1 of the following: * High-risk cytogenetics, such as t(9;22), t(1;19), t(4;11), or other MLL rearrangements * More than 1 course of therapy was required to obtain a CR * In second or greater CR by morphology * In morphologic relapse or persistent disease as defined for AML * In cytogenetic relapse (without morphologic relapse) * Chronic myelogenous leukemia * All types allowed except refractory blast crisis * Non-Hodgkin's lymphoma (NHL) * No intermediate- or high-grade NHL or mantle cell NHL that is progressive on salvage therapy * Stable disease allowed provi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety as assessed by a non-relapse mortality < 30% within day 100

Trial details

NCT IDNCT00365287

SponsorMasonic Cancer Center, University of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-12

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