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.

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
treatment

- 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
cancers)

- 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
conditioning

- 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