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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


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Graft vs tumor effect as measured by CT scan at days 30, 60, and 100 following transplant

Safety Issue:

No

Principal Investigator

Richard W. Childs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

Unspecified

Study ID:

CDR0000066610

NCT ID:

NCT00003553

Start Date:

January 1999

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

NIH - Warren Grant Magnuson Clinical CenterBethesda, Maryland  20892-1182