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Phase I/II Study of HLA-Matched Non-Myeloablative Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation as Treatment for Patients With Metastatic Renal Cell Carcinoma. A Multi-Center Trial.

Phase 1/Phase 2
74 Years
Open (Enrolling)
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

Phase I/II Study of HLA-Matched Non-Myeloablative Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation as Treatment for Patients With Metastatic Renal Cell Carcinoma. A Multi-Center Trial.


I. To determine whether mixed or full donor hematopoietic chimerism can be safely
established using a non-myeloablative conditioning regimen.

II. To determine whether mixed chimerism can be safely converted to full donor hematopoietic
chimerism by infusions of donor lymphocytes (DLI).

III. To evaluate potential efficacy of this approach as a treatment for metastatic renal


CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4
to -2 and undergo low-dose total body irradiation (TBI) on day 0.

TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.

IMMUNOSUPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) or IV once
daily (QD) or BID on days -3 to 35 with taper to day 56, and mycophenolate mofetil PO or IV
over 2 hours thrice daily (TID) on days 0-40.

DLI: Patients with stable mixed chimerism on day 56 with no evidence of graft-vs-host
disease (GVHD) may receive escalating doses of non-mobilized DLI over 30 minutes. Patients
may receive up to 4 DLIs at escalating doses if there is disease progression with no
evidence of GVHD.

After completion of study treatment, patients are followed up periodically for 5 years.

Inclusion Criteria:

- Patients with histologically confirmed stage IV renal cancer who have stable
(including those rendered to be in remission) or progressive disease

- Human lymphocyte antigen (HLA) genotypically identical related donor willing to
undergo leukapheresis initially for collection of peripheral blood stem cells (PBSC)
and subsequently for collection of peripheral blood monocytic cells (PBMC)

- Ionized calcium level within normal limits

- DONOR: HLA genotypically identical family member (excluding identical twins)

- DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis

- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
central venous catheter (femoral, subclavian)

- DONOR: Age < 75 years

Exclusion Criteria:

- Patients who have positive serologies for human immunodeficiency virus (HIV)1 and 2,
human T-lymphotropic virus (HTLV)-1

- Patients unwilling to use contraceptive techniques during and for 12 months following

- Serum creatinine > 2.0; the Fred Hutchinson Cancer Research Center (FHCRC) Patient
Care Conference (PCC) may approve patients with elevated serum creatinine following
presentation and approval; centers outside the FHCRC that have a PCC or equivalent
should obtain their institutional approval; if there is not a comparable group at the
institution, please contact the FHCRC principal investigator for FHCRC approval
through PCC

- Cardiac ejection fraction < 50%; ejection fraction is required if the patient has a
history of anthracyclines or history of cardiac disease

- Diffusion capacity of carbon monoxide (DLCO) < 50% of predicted, total lung capacity
(TLC) < 50%, forced expiratory volume in one second (FEV1) < 50%

- Liver function tests including total bilirubin, serum glutamic pyruvate transaminase
(SGPT) and serum glutamic oxaloacetic transaminase (SGOT) > 2 x the upper limit of
normal unless due to the malignancy

- Karnofsky score < 80

- Brain metastasis

- Ongoing active bacterial, viral or fungal infection

- Pregnancy or breastfeeding

- Patients with other active non-hematologic malignancies (except non-melanoma skin

- Patients with a history of other non-hematologic malignancies (except non-melanoma
skin cancers) currently in a complete remission, who are less than 5 years from the
time of complete remission, and have a > 20% risk of disease recurrence

- The addition of cytotoxic agents for "cytoreduction" with the exception of Gleevec
(imatinib mesylate), cytokine therapy, hydroxyurea, low dose cytarabine,
chlorambucil, or rituxan will not be allowed within three weeks of the initiation of

- DONOR: Age less than 12 years

- DONOR: Pregnancy

- DONOR: Infection with HIV

- DONOR: Inability to achieve adequate venous access

- DONOR: Known allergy to G-CSF

- DONOR: Current serious systemic illness

- DONOR: Failure to meet criteria for donation as described in the Standard Practice
Guidelines of the institution

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

True response rate (complete response [CR] or partial response [PR]) greater than the 15% achievable with standard therapy

Outcome Description:

If 6 or more out of 25 patients achieve a CR or PR, then we will be at least 80% confident that the true response rate exceeds 15% and that this approach is potentially efficacious.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Brenda Sandmaier

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell



Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Rocky Mountain Cancer Center Denver, Colorado  80218
Baylor University Medical Center Dallas, Texas  75246
VA Puget Sound Health Care System Seattle, Washington  98101
University of Arizona Health Sciences Center Tucson, Arizona  85724
Froedtert Memorial Lutheran Hospital, Medical College of Wisconsin Milwaukee, Wisconsin  53226