A Phase 2 interventional study of Myeloablative Chemotherapy and Stem Cell Rescue in Wilms Tumor, Fibrosarcoma and Carcinoma, Round Cell, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2014-06-20.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether very high dosages of chemotherapy will improve the chance of surviving cancer.
This is a phase II trial designed to provide a transplant option for patients with rare poor-prognosis cancers. The protocol is only open to patients with metastatic or relapsed cancers for whom the probability of remaining free of progressive disease for one year after being brought into remission is \< 25%. Patients eligible for this study have been diagnosed with a form of cancer that leads to death more than 75% of the time when treated with standard therapy doses of chemotherapy and/ or radiation therapy. Under this treatment intensification protocol the expectation is that the one year progression-free survival for this group of patients will rise to 40%. Patients eligible for this protocol will be followed for one year post-transplant. Patients alive and free of progressive disease at the end of this period will be considered successes.
200 studies on the registry are indexed under Wilms Tumor; 25 are open to participants now.
This study's enrollment of 25 is below the median of 28 across 139 interventional studies indexed under Wilms Tumor.
Browse Wilms Tumor studies →University of Michigan Rogel Cancer Center is the lead sponsor of 323 studies on the registry; 47 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a -confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor, which:
Disease status: Within 3 weeks of initiation of this protocol, patients must:
Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy. Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue. The cancer must be proven to be sensitive to alkylating agents. This means that, in addition to, or as part of, the appropriate chemotherapy protocol for the specific cancer in question, all patients must have received and responded to a minimum of:
Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Myeloablative Chemotherapy, followed by stem cell rescue
Procedure: Myeloablative Chemotherapy · Procedure: Stem Cell Rescue
High dose chemotherapy (carboplatin and thiotepa) transplant rescue
autologous stem cell transplantation
Percent of Participants With Progression Free Survival at 1 Year
The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.
Time frame: 1 year post transplant
| Milestone | Myeloablative Chemotherapy With Stem Cell Rescue |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.
| percentage of participants | Myeloablative Chemotherapy With Stem Cell Rescue |
|---|---|
| Percent of Participants With Progression Free Survival at 1 Year | 58 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Myeloablative Chemotherapy With Stem Cell Rescue | — | 19/25 (76%) | 12/25 (48%) |
| Event | Myeloablative Chemotherapy With Stem Cell Rescue |
|---|---|
| InfectionInfections and infestations | 11/25 |
| MucocitisGastrointestinal disorders | 10/25 |
| FeverGeneral disorders | 6/25 |
| DeathGeneral disorders | 2/25 |
| DiarrheaGastrointestinal disorders | 2/25 |
| TachypneaRespiratory, thoracic and mediastinal disorders | 2/25 |
| Neutropenic FeverBlood and lymphatic system disorders | 2/25 |
| HypokalemiaMetabolism and nutrition disorders | 2/25 |
| HypcalcemiaMetabolism and nutrition disorders | 2/25 |
| ThrombocytopeniaInvestigations | 1/25 |
| Event | Myeloablative Chemotherapy With Stem Cell Rescue |
|---|---|
| HypokalemiaMetabolism and nutrition disorders | 8/25 |
| Total BilirubinInvestigations | 6/25 |
| ASTInvestigations | 6/25 |
| HypocalcemiaMetabolism and nutrition disorders | 5/25 |
| ALTInvestigations | 5/25 |
| HyperglycemiaMetabolism and nutrition disorders | 4/25 |
| HypoalbuminemiaMetabolism and nutrition disorders | 4/25 |
| HypomagnesemiaMetabolism and nutrition disorders | 3/25 |
| ALKInvestigations | 3/25 |
| HyperkalemiaMetabolism and nutrition disorders | 3/25 |
| Age, Continuous(years) | Myeloablative Chemotherapy With Stem Cell Rescue |
|---|---|
| Mean | 6 (1 to 21) |
| Sex: Female, Male(Participants) | Myeloablative Chemotherapy With Stem Cell Rescue |
|---|---|
| Female | 12 |
| Male | 13 |
The record gives a start of Jan 1997, a primary completion of Dec 2008 and a completion of Feb 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2014, 5 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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