Fludarabine Phosphate |
Fludara |
Clinical Trial: Peripheral Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) November 2006
Purpose
RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient’s immune system from rejecting the donor’s stem cells. The donated stem cells may replace the patient’s immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor’s T cells (donor lymphocyte infusion) after the transplant may help increase this effect.
PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Kidney Cancer | Drug: cyclophosphamide Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Procedure: biological therapy Procedure: bone marrow ablation with stem cell support Procedure: chemotherapy Procedure: graft versus tumor induction Procedure: leukocyte therapy Procedure: peripheral blood lymphocyte therapy Procedure: peripheral blood stem cell transplantation | Phase II |
MedlinePlus related topics: Cancer; Kidney Cancer
Genetics Home Reference related topics: Cancer; Kidney Cancer
Study Type: Interventional
Study Design: Treatment, Open Label
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
Secondary Outcome Measures:
- Disease-free survival by CAT scan at 6 months and 1 year
Total Enrollment: 80
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: This is a dose-escalation study of a conditioning regimen. (Dose escalation completed as of 10/1/03.)
Patients receive 1 of 3 dose levels of conditioning chemotherapy prior to peripheral blood progenitor cell (PBPC) transplantation. (Dose levels 2 and 3 are closed to accrual as of 10/1/03.)
- Dose level 1: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes daily on days -5 to -1.
- Dose level 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 daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2.
- Dose level 3 (closed to accrual as of 10/1/03): Patients receive cyclophosphamide IV over 1 hour daily on days -8 to -6, fludarabine IV over 30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2.
Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may be repeated on days 1 and 2 if deemed necessary.
Patients with progressive disease on days 15-30, day 60, or day 100, without graft-versus-host disease, 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 2.5 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Eligibility
DISEASE CHARACTERISTICS:
- Histologically proven metastatic renal cell carcinoma not amenable to complete surgical resection and progressive despite immunotherapy
- Bidimensionally evaluable clinically or radiographically
- HLA 6/6 or 5/6 matched family donor available
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 80
Performance status:
- ECOG 0 or 1
Life expectancy:
- At least 3 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 4 mg/dL
- Transaminases no greater than 3 times upper limit of normal
Renal:
- Creatinine no greater than 2.5 mg/dL
- No malignancy-associated hypercalcemia (< 2.5 mmol/L)
Cardiovascular:
- Left ventricular ejection fraction greater than 40%
Pulmonary:
- DLCO greater than 65% of predicted
Other:
- Not pregnant
- HIV negative
- No major organ dysfunction that would preclude transplantation
- No other malignancies except basal cell or squamous cell skin cancer
- No psychiatric disorder or mental deficiency that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 1 month since prior treatment for renal cell carcinoma
Location and Contact Information
United States, Maryland
NIH - Warren Grant Magnuson Clinical Center, Bethesda, Maryland, 20892-1182, United States; Recruiting
Richard W. Childs, MD, Study Chair, National Heart, Lung, and Blood Institute (NHLBI)
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
Carvallo C, Geller N, Kurlander R, Srinivasan R, Mena O, Igarashi T, Griffith LM, Linehan WM, Childs RW. Prior chemotherapy and allograft CD34+ dose impact donor engraftment following nonmyeloablative allogeneic stem cell transplantation in patients with solid tumors. Blood. 2004 Feb 15;103(4):1560-3. Epub 2003 Oct 9.
Publications that report results of this study
Childs R, Chernoff A, Contentin N, Bahceci E, Schrump D, Leitman S, Read EJ, Tisdale J, Dunbar C, Linehan WM, Young NS, Barrett AJ. Regression of metastatic renal-cell carcinoma after nonmyeloablative allogeneic peripheral-blood stem-cell transplantation. N Engl J Med. 2000 Sep 14;343(11):750-8.
Last Updated: March 5, 2007
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003553
Obsolete Identifier: NCT00001635
Health Authority: Unspecified
ClinicalTrials.gov processed this record on May 14, 2007
Resources
- Fludara (Drug Digest)
- Fludarabine Phosphate (Drug Digest)

Not Signed In -


