Wilms TumorPhase 2NCT00141765
Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers
A Phase 2 study testing Myeloablative Chemotherapy and Stem Cell Rescue in people with Wilms Tumor and Fibrosarcoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether very high dosages of chemotherapy will improve the chance of surviving cancer. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Wilms Tumor, Fibrosarcoma, Carcinoma, Round Cell
- What is being tested?
- Myeloablative Chemotherapy and Stem Cell Rescue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1997to Feb 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-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:
- is metastatic and has < 25% cure rate with conventional treatment; or
- progressed after prior chemotherapy and has < 25% salvage rate with non-myeloablative therapies.
- Disease status: Within 3 weeks of initiation of this protocol, patients must:
- be in a complete or good partial remission (section 7.4); or
- have a "chemosensitive" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy, without evidence of progressive disease by any other parameter.
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- 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:
- 2 courses of high-dose cyclophosphamide, totaling > 4200 mg/m2; or
- courses of high-dose ifosfamide totaling > 12 gm/m2.
- 1 course of "a)" above, plus 1 course of 'b)" above.
- Equivalent high dose alkylating agents as described in 3.3 a, b, and c.
- Patients must have adequate renal hepatic, and cardiac function (sections 4.4-4.6).
- Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):
- Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or,
- Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.
- Informed consent must be signed indicating patient and/or parental awareness of the investigational nature of this program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Myeloablative Chemotherapy With Stem Cell Rescue for Rare Poor-Prognosis Cancers
The purpose of this study is to determine whether very high dosages of chemotherapy will improve the chance of surviving cancer.
Read the detailed description
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.
- Conditions
- Wilms Tumor, Fibrosarcoma, Carcinoma, Round Cell, Nasopharyngeal Cancer, Brain Tumor, Recurrent
- Being tested
- Myeloablative Chemotherapy, Stem Cell Rescue
- Medical subject headings
- Wilms Tumor, Fibrosarcoma, Carcinoma, Nasopharyngeal Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myeloablative ChemotherapyProcedure or surgery
High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell RescueProcedure or surgery
autologous stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Myeloablative Chemotherapy with Stem Cell Rescue | Experimental | Myeloablative Chemotherapy, followed by stem cell rescue Receives: Procedure: Myeloablative Chemotherapy; Procedure: Stem Cell Rescue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJan 1997
- Primary completionDec 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wilms TumorStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Levine, MD, University of Michigan Rogel Cancer Center
- Investigators
- John E. Levine, MS MD, Principal investigator, The Univeristy of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141765
- Sponsor's protocol ID
- UMCC 9626
- Other IDs
- IRB 1996-195
- Status last verified
- May 2014
- First submitted
- 31 Aug 2005
- Last updated
- 20 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloablative Chemotherapy With Stem Cell Rescue for Rare Poor-Prognosis Cancers
- ClinicalTrials.gov ID
- NCT00141765
- Acronym / sponsor ID
- UMCC 9626
- Conditions
- Wilms Tumor, Fibrosarcoma, Carcinoma, Round Cell, Nasopharyngeal Cancer, Brain Tumor, Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Jan 1997
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Posted 20 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether very high dosages of chemotherapy will improve the chance of surviving cancer.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myeloablative Chemotherapy with Stem Cell Rescue | Experimental | Procedure: Myeloablative Chemotherapy, Procedure: Stem Cell RescueMyeloablative Chemotherapy, followed by stem cell rescue |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-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 have adequate renal hepatic, and cardiac function (sections 4.4-4.6).
- Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myeloablative ChemotherapyHigh dose chemotherapy (carboplatin and thiotepa) transplant rescue | Procedure or surgery | Myeloablative Chemotherapy with Stem Cell Rescue |
| Stem Cell Rescueautologous stem cell transplantation | Procedure or surgery | Myeloablative Chemotherapy with Stem Cell Rescue |
Primary outcome
Percent of Participants With Progression Free Survival at 1 Year
Time frame: 1 year post transplant
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E. Levine, MS MD principal investigator
The Univeristy of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Myeloablative Chemotherapy and Stem Cell Rescue in people with Wilms Tumor and Fibrosarcoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants With Progression Free Survival at 1 Year (time frame: 1 year post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2014.