Kidney CancerPhase 2NCT00056095
Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing therapeutic allogeneic lymphocytes, cyclophosphamide and cyclosporine in people with Kidney Cancer, run by UNICANCER at 26 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- therapeutic allogeneic lymphocytes, cyclophosphamide and cyclosporine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 26 sitesFrance
- Study dates
- 4 Nov 2002to 17 Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic renal cell carcinoma
- No sarcomatoid, pure papillary, or Bellini renal cell cancer
- Measurable and/or evaluable disease
- Disease progression after at least 1 immunotherapy regimen for metastatic disease
- Localized metastases allowed provided the following are true:
- At least 3 months since prior treatment for metastases
- Not considered likely to influence outcome of transplantation
- No brain metastases unless treated surgically or radiologically and MRI normal
- Sufficiently healthy, HLA-compatible family member must be available as donor for patients undergoing stem cell transplantation
PATIENT CHARACTERISTICS:
Age
- 18 to 65
Performance status
- ECOG 0-1
Life expectancy
- More than 6 months
Hematopoietic
- Platelet count at least 100,000/mm^3
Hepatic
- Transaminases less than 1.5 times upper limit of normal (ULN)*
- Bilirubin less than 1.5 times ULN* NOTE: *Unless due to Gilbert's disease
Renal
- No renal insufficiency
- Calcium less than 10.4 mg/dL
- Creatinine clearance greater than 50 mL/min
Cardiovascular
- Ejection fraction greater than 50%
Pulmonary
- No DLCO that would preclude fludarabine or busulfan therapy
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No physical obstacle to receiving study treatment
- No known autoimmune disease
- No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- No uncontrolled bacterial, viral, or fungal infection
- No prior or concurrent psychiatric disease
- HIV negative
- HTLV1 negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- No tolerance to fludarabine and busulfan
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Centre Hospitalier Regional et Universitaire d'Angers
Angers, 49033
Centre Paul Papin
Angers, 49100
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, 25030
Hopital Saint Andre
Bordeaux, 33075
Chu-Hopital Gabriel Montpied
Clermont-Ferrand, 63003
Centre Jean Perrin
Clermont-Ferrand, 63011
CHU de Grenoble - Hopital Michallon
Grenoble, 38043
Centre Oscar Lambret
Lille, 59020
Centre Hospital Universitaire Hop Huriez
Lille, 59037
Centre Hospital Regional Universitaire de Limoges
Limoges, 87042
Centre Leon Berard
Lyon, 69373
Hopital Edouard Herriot - Lyon
Lyon, 69437
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
Hopital Lapeyronie-CHU Montpellier
Montpellier, 34295
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Hopital de l'Archet CHU de Nice
Nice, F-06202
Institut Curie Hopital
Paris, 75248
Hopital Haut Leveque
Pessac, 33604
Hopital Jean Bernard
Poitiers, 86021
Centre Hospitalier Universitaire de Rennes
Rennes, 35033
Centre Eugene Marquis
Rennes, 35042
Centre Henri Becquerel
Rouen, 76038
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, F-94805
About this study
Official title: Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.
Read the detailed description
OBJECTIVES:
- Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation.
- Determine the objective rate of response of patients treated with this regimen.
- Determine post-transplant immunological reactions and recuperation of patients treated with this regimen.
- Determine the antitumoral activity of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study. Patients are assigned to 1 of 2 treatment groups based on availability of a compatible family member for stem cell transplantation.
- Group I: Patients with a compatible family donor receive conditioning chemotherapy comprising cyclophosphamide IV over 2 hours on days -7 and -6 and fludarabine IV once daily on days -5 to -1. Patients undergo filgrastim (G-CSF)-mobilized allogeneic stem cell transplantation on day 0. Patients also receive immunosuppression therapy with cyclosporine beginning on day -2. Patients who have persistent or progressive disease, mixed chimerism, and no evidence of grade 2 or greater graft-vs-host disease, and have been off immunosuppression therapy for 1-2 weeks receive donor lymphocyte infusion on days 7 and 21.
- Group II: Patients without a compatible family donor receive treatment (immunotherapy, vaccination therapy, or chemotherapy) at the discretion of the treating physician.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 170 patients (60 patients for group I and 110 patients for group II) will be accrued for this study within 3 years.
- Conditions
- Kidney Cancer
- Being tested
- therapeutic allogeneic lymphocytes, cyclophosphamide, cyclosporine, fludarabine phosphate, allogeneic bone marrow transplantation
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic allogeneic lymphocytesBiological
cyclophosphamideDrug
cyclosporineDrug
allogeneic bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Allograft (compatible family member) | Experimental | Not described Receives: Biological: therapeutic allogeneic lymphocytes; Drug: cyclophosphamide; Drug: cyclosporine; Drug: fludarabine phosphate; Procedure: allogeneic bone marrow transplantation; Procedure: peripheral blood stem cell transplantation |
| Allograft (compatible non-family member) | Other | Not described Receives: Procedure: allogeneic bone marrow transplantation; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate at 18 months
Objective rate of response
Post-transplant immunological reactions and recuperation
Antitumoral activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study start4 Nov 2002
- Primary completion13 Feb 2008
- Study completion17 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Blaise, MD, Study chair, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056095
- Sponsor's protocol ID
- UC-0160/0105
- Other IDs
- FRE-FNCLCC-GETUG-11/0105, EU-20234
- Status last verified
- Feb 2021
- First submitted
- 6 Mar 2003
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
- ClinicalTrials.gov ID
- NCT00056095
- Acronym / sponsor ID
- UC-0160/0105
- Conditions
- Kidney Cancer
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 4 Nov 2002 (actual)
- Primary completion
- 13 Feb 2008 (actual)
- Study completion
- 17 Aug 2016 (actual)
- First posted
- 7 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.
Detailed description
OBJECTIVES:
- Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation.
- Determine the objective rate of response of patients treated with this regimen.
- Determine post-transplant immunological reactions and recuperation of patients treated with this regimen.
- Determine the antitumoral activity of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study. Patients are assigned to 1 of 2 treatment groups based on availability of a compatible family member for stem cell transplantation.
- Group I: Patients with a compatible family donor receive conditioning chemotherapy comprising cyclophosphamide IV over 2 hours on days -7 and -6 and fludarabine IV once daily on days -5 to -1. Patients undergo filgrastim (G-CSF)-mobilized allogeneic stem cell transplantation on day 0. Patients also receive immunosuppression therapy with cyclosporine beginning on day -2. Patients who have persistent or progressive disease, mixed chimerism, and no evidence of grade 2 or greater graft-vs-host disease, and have been off immunosuppression therapy for 1-2 weeks receive donor lymphocyte infusion on days 7 and 21.
- Group II: Patients without a compatible family donor receive treatment (immunotherapy, vaccination therapy, or chemotherapy) at the discretion of the treating physician.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 170 patients (60 patients for group I and 110 patients for group II) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allograft (compatible family member) | Experimental | Biological: therapeutic allogeneic lymphocytes, Drug: cyclophosphamide, Drug: cyclosporine, Drug: fludarabine phosphate, Procedure: allogeneic bone marrow transplantation, Procedure: peripheral blood stem cell transplantation |
| Allograft (compatible non-family member) | Other | Procedure: allogeneic bone marrow transplantation, Procedure: peripheral blood stem cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| therapeutic allogeneic lymphocytes | Biological | Allograft (compatible family member) |
| cyclophosphamide | Drug | Allograft (compatible family member) |
| cyclosporine | Drug | Allograft (compatible family member) |
| fludarabine phosphate | Drug | Allograft (compatible family member) |
| allogeneic bone marrow transplantation | Procedure or surgery | Allograft (compatible family member), Allograft (compatible non-family member) |
| peripheral blood stem cell transplantation | Procedure or surgery | Allograft (compatible family member), Allograft (compatible non-family member) |
Primary outcome
Survival rate at 18 months
Objective rate of response
Post-transplant immunological reactions and recuperation
Antitumoral activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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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.
Didier Blaise, MD study chair
Institut Paoli-Calmettes
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing therapeutic allogeneic lymphocytes, cyclophosphamide and cyclosporine in people with Kidney Cancer, run by UNICANCER at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival rate at 18 months. The study lists 4 primary outcomes in all. 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 24 Feb 2021.