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Trial: NCT00003553 [RDF]

Label NCT00003553
Slug nct00003553
Trialid NCT00003553
Lookup name NCT00003553
Provenance http://clinicaltrials.gov/show/NCT00003553?displayxml=true
Lastchanged date June 23, 2009
Firstreceived results date
Firstreceived date November 1, 1999
Id info nct id NCT00003553
Overall status Recruiting
Id info secondary id NHLBI-97-H-0196
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 80
Number of arms 6
Is section 801 Yes
Is fda regulated Yes
Brief title Peripheral Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Acronym
Official title A Phase II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation for Metastatic Renal Cell Carcinoma Followed by Allogeneic T-Cell Infusion as Adoptive Immunotherapy
Study type Interventional
Id info nct alias NCT00001635
Completion date
Verification date June 2009
Why stopped
Id info org study id CDR0000066610
Required header url https://clinicaltrials.gov/show/NCT00003553
Study design Masking: Open Label, Primary Purpose: Treatment
Source National Cancer Institute (NCI)
Primary completion date December 2009
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 08, 2016
Phase Phase 2
Start date January 1999
Has expanded access No
Biospec descr
Detailed description OBJECTIVES: - Determine the antitumor effect of allogeneic peripheral blood stem cell transplantation (PBSCT) in patients with metastatic renal cell carcinoma. - Evaluate the safety and toxicity of a nonmyeloablative, low-intensity, preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients. - Determine engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in patients treated with this regimen. - Determine the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen. - Determine the effect of lymphocyte infusions on donor-host chimerism in this patient population. - Determine the response rate, disease-free survival, overall survival, and mortality from the procedure or tumor progression in patients treated with this regimen. OUTLINE: - Nonmyeloablative preparative regimen: Patients receive 1 of 3 preparative regimens prior to peripheral blood progenitor cell (PBPC) transplantation. (Regimens 2 and 3 closed to accrual as of 10/1/03.) - Regimen 1: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1. - Regimen 2 (closed to accrual as of 10/1/03): Patients receive cyclophosphamide IV over 1 hour on days -7 and -6, fludarabine IV over 30 minutes on days -5 to -1, and antithymocyte globulin on days -5 to -2. - Regimen 3 (closed to accrual as of 10/1/03): Patients receive cyclophosphamide IV over 1 hour on days -8 to -6, fludarabine IV over 30 minutes on days -5 to -1, and antithymocyte globulin on days -5 to -2. - PBPC transplantation: Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may be repeated on days 1 and 2, if deemed necessary. - Graft-versus-host disease (GVHD) prophylaxis: Patients receive 1 of 3 GVHD prophylaxis regimens. - Regimen 1 (closed to accrual as of 10/17/00): Patients receive cyclosporine IV over 12 hours or orally beginning on day -4 and continuing for up to approximately 3 months. - Regimen 2 (open to accrual from 10/17/00 through 2/11/02): Patients receive cyclosporine as in regimen 1. Patients also receive mycophenolate mofetil. - Regimen 3 (open to accrual as of 2/11/02): Patients receive cyclosporine as in regimen 1. Patients also receive methotrexate. - Donor lymphocyte infusions: Patients with progressive disease on days 15-30, day 60, or day 100, without GVHD, receive infusion(s) of donor lymphocytes. Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician. Patients are followed every 2 months for 6 months, every 3 months for 2 years, and then every 6 months for 2½ years. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Condition browse b1cd5567003a74fc35e8a175a9a2484b
Intervention browse bb4c84d6ab59d86a49bf6fa813375171
Responsible party e6d05f7508abeb9626e11487c5334b88
Overall contact None
Overall contact backup None
Sponsor group 751f3b74397f1130554ff179c9552666
Oversight info Unspecified (Oversight_info)
Eligibility 52af484a1aea77150c3a9f454226b302
Keywords recurrent renal cell cancer, stage IV renal cell cancer
Conditions Kidney Cancer
Locations 9a70401b1de2de8fe1e70eeb4cd6f311
Links None
Results references PMID:10984562
Arm groups GVHD regimen 1 (closed to accrual as of 10/17/00) (Arm Group), Preparative regimen 2 (closed to accrual as of 10/1/03) (Arm Group), Preparative regimen 3 (closed to accrual as of 10/1/03) (Arm Group), GVHD regimen 3 (open to accrual as of 2/11/02) (Arm Group), GVHD regimen 2 (open to accrual from 10/17/00 through 2/11/02) (Arm Group), Preparative regimen 1 (Arm Group)
Location countries United States
Interventions cyclosporine (Intervention), methotrexate (Intervention), anti-thymocyte globulin (Intervention), cyclophosphamide (Intervention), fludarabine phosphate (Intervention), mycophenolate mofetil (Intervention)
Secondary outcomes 86870f06d69a02f931247fbbaa61b1d7
References PMID:14551148
Primary outcomes bce7b3a08ac19759d2a0d9d218596721
Removed countries None
Overall officials 8f446a5e1dd75beac1feecb6da0cc9b7