Kidney CancerPhase 2NCT00025519
Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Kidney Cancer
A Phase 2 study testing therapeutic allogeneic lymphocytes, fludarabine phosphate and mycophenolate mofetil in people with Kidney Cancer, run by Fox Chase Cancer Center.
Trial summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's tissues. 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, fludarabine phosphate and mycophenolate mofetil
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Oct 2006
- 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 renal cell carcinoma (RCC)
- Histology demonstrates major clear cell component
- Metastatic (stage IV) or recurrent disease
- Prior debulking nephrectomy required
- Disease not amenable to complete surgical resection
- Must have HLA-identical donor
- Matched related sibling donors must have 6/6 serologic HLA A, B, and DR match with molecular confirmation at DRB1
- A 5/6 serologic mismatch with one antigen mismatch at locus A or B (not DR) with molecular confirmation at locus A, B, and DRB1 allowed
- Matched unrelated donors must have a minimum of 8 out of 10 molecular matches at loci A, B, C, DRB1, and DQB1
- No brain metastases
- Negative MRI required
PATIENT CHARACTERISTICS:
Age:
- 18 to 65
Performance status:
- Karnofsky 80-100% OR
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2 times upper limit of normal (ULN)
- ALT/AST less than 2 times ULN
- Alkaline phosphatase less than 2 times ULN
- Hepatitis A, B, and C negative
Renal:
- Creatinine clearance greater than 50 mL/min
- Calcium less than 10.5 mg/dL (bisphosphonates allowed)
Cardiovascular:
- LVEF no less than 10% below lower limit of normal
Pulmonary:
- FEV_1 and DLCO greater than 50%
Other:
- HIV negative
- No active bacterial, fungal, or viral (including cytomegalovirus) infections
- No intolerance or allergy to tacrolimus, mycophenolate mofetil, or fludarabine
- No intolerance to 200 cGy of total body irradiation
- No other serious comorbid disease, neurologic condition, or psychosocial condition that would preclude study follow-up
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior interleukin-2 allowed
- Prior interferon alfa allowed
Chemotherapy:
- Prior chemotherapy allowed
- No other concurrent chemotherapy for RCC
Endocrine therapy:
- No concurrent corticosteroids for other comorbid disease
Radiotherapy:
- No prior extensive radiotherapy to marrow microenvironment greater than 20% of total marrow mass
- No prior radiotherapy that has reached tissue tolerance for heart, lung, liver, kidney, or spinal cord
Surgery:
- See Disease Characteristics
Other:
- No other concurrent therapy for RCC
- No concurrent enrollment on another investigational protocol for treatment of RCC
- No other concurrent immunosuppressive medications
- No other concurrent investigational drugs
About this study
Official title: Submyeloablative Allogeneic Blood Stem Cell Transplantation With HLA Identical Donor Lymphocyte Infusions From Matched Related and Matched Unrelated Donors for Treatment of Metastatic Renal Cell Carcinoma
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's tissues. Mycophenolate mofetil, tacrolimus, and donor white blood cells may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic or recurrent kidney cancer.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of submyeloablative HLA-identical allogeneic peripheral blood stem cell transplantation in patients with metastatic or recurrent renal cell carcinoma.
- Determine the toxicity of this regimen, in terms of incidence and severity of graft rejection, acute graft-vs-host disease (GVHD), chronic GVHD, adverse effects from the preparative regimen and thalidomide, and infection and bleeding, in these patients.
- Determine the efficacy of this regimen, in terms of objective partial and complete response rates, in these patients.
- Determine the engraftment rates and extent of chimerism in patients treated with this regimen.
- Determine the overall survival and time to treatment failure rate in patients treated with this regimen.
- Determine the impact of thalidomide on the treatment of chronic GVHD in patients treated with this regimen.
OUTLINE: Patients are stratified according to risk (low vs high).
Patients receive fludarabine IV over 30 minutes once daily on days -4 to -2 followed by total body irradiation on day -1. Patients receive tacrolimus IV over 24 hours or orally daily on days -3 to 35 and oral mycophenolate mofetil twice daily on days -3 to 28 as graft-vs-host disease (GVHD) prophylaxis. Patients undergo allogeneic peripheral blood stem cell transplantation over 1-2 hours on day 0.
Patients maintaining a mixed chimerism with no evidence of grade III or IV GVHD receive donor lymphocyte infusions (DLI) on days 60, 90, and 120. Patients may receive additional DLI as needed. Patients with limited chronic GVHD receive oral thalidomide daily beginning after day 80 and continuing for 1 year or until disease progression or resolution of chronic GVHD.
Patients are followed at 1, 3, 6, and 12 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 20-40 patients (10-20 per stratum) will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- therapeutic allogeneic lymphocytes, fludarabine phosphate, mycophenolate mofetil, tacrolimus, thalidomide
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma
- 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
tacrolimusDrug
thalidomideDrug
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2001
- Primary completionOct 2006
- Study completionOct 2006
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 Fox Chase 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary R. Hudes, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025519
- Sponsor's protocol ID
- FCCC-01006
- Other IDs
- CDR0000068970, TUHSC-3721, NCI-G01-2021
- Status last verified
- Jul 2013
- First submitted
- 11 Oct 2001
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submyeloablative Allogeneic Blood Stem Cell Transplantation With HLA Identical Donor Lymphocyte Infusions From Matched Related and Matched Unrelated Donors for Treatment of Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00025519
- Acronym / sponsor ID
- FCCC-01006
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2001
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 27 Jan 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: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's tissues. Mycophenolate mofetil, tacrolimus, and donor white blood cells may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic or recurrent kidney cancer.
Detailed description
OBJECTIVES:
- Determine the feasibility of submyeloablative HLA-identical allogeneic peripheral blood stem cell transplantation in patients with metastatic or recurrent renal cell carcinoma.
- Determine the toxicity of this regimen, in terms of incidence and severity of graft rejection, acute graft-vs-host disease (GVHD), chronic GVHD, adverse effects from the preparative regimen and thalidomide, and infection and bleeding, in these patients.
- Determine the efficacy of this regimen, in terms of objective partial and complete response rates, in these patients.
- Determine the engraftment rates and extent of chimerism in patients treated with this regimen.
- Determine the overall survival and time to treatment failure rate in patients treated with this regimen.
- Determine the impact of thalidomide on the treatment of chronic GVHD in patients treated with this regimen.
OUTLINE: Patients are stratified according to risk (low vs high).
Patients receive fludarabine IV over 30 minutes once daily on days -4 to -2 followed by total body irradiation on day -1. Patients receive tacrolimus IV over 24 hours or orally daily on days -3 to 35 and oral mycophenolate mofetil twice daily on days -3 to 28 as graft-vs-host disease (GVHD) prophylaxis. Patients undergo allogeneic peripheral blood stem cell transplantation over 1-2 hours on day 0.
Patients maintaining a mixed chimerism with no evidence of grade III or IV GVHD receive donor lymphocyte infusions (DLI) on days 60, 90, and 120. Patients may receive additional DLI as needed. Patients with limited chronic GVHD receive oral thalidomide daily beginning after day 80 and continuing for 1 year or until disease progression or resolution of chronic GVHD.
Patients are followed at 1, 3, 6, and 12 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 20-40 patients (10-20 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 | – |
| fludarabine phosphate | Drug | – |
| mycophenolate mofetil | Drug | – |
| tacrolimus | Drug | – |
| thalidomide | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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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.
Gary R. Hudes, MD study chair
Fox Chase Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing therapeutic allogeneic lymphocytes, fludarabine phosphate and mycophenolate mofetil in people with Kidney Cancer, run by Fox Chase Cancer Center.
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: withdrawn, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 11 Jul 2013.