Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Study of Peripheral Stem Cell Transplant After Chemotherapy and Radiation Therapy in Treating Patients With Metastatic Kidney Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed Under 75 NCI FHCRC-1495.00 NCI-G00-1790, NCT00005851

Objectives

1. Determine if mixed or full donor hematopoietic chimerism can be safely achieved with nonmyeloablative conditioning therapy in patients with metastatic renal cell carcinoma.
2. Determine if mixed chimerism can be safely converted to full donor hematopoietic chimerism with donor lymphocyte infusions in this patient population.
3. Determine the efficacy of this treatment regimen in this patient population.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IV renal cell carcinoma
  • Stable or progressive disease



• HLA genotypically identical related donor
  • No identical twins



• No brain metastasis

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent growth factors during mycophenolate mofetil administration

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age:

• Under 75

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)*
• SGOT and SGPT no greater than 2 times ULN*

 [Note: * Unless due to malignancy]

Renal:

• Creatinine no greater than 2.0 mg/dL
• Calcium normal

Cardiovascular:

• Ejection fraction at least 50%

Pulmonary:

• DLCO at least 50% of predicted

Other:

• HIV-1 and HIV-2 negative
• HTLV-1 negative
• No ongoing active bacterial, viral, or fungal infection
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 12 months after study participation

Expected Enrollment

A total of 25 patients will be accrued for this study within 3 years.

Outcomes

Disease response
Safety as measured by transplant related mortality on day 200 after allografting
Donor engraftment on day 56 after allografting

Outline

This is a multicenter study.

Patients receive fludarabine IV on days -4 to -2 and undergo total body irradiation followed by filgrastim (G-CSF)-mobilized HLA-matched allogeneic peripheral blood stem cell transplantation on day 0.

Patients receive immunosuppressive therapy comprising oral cyclosporine twice daily beginning on day -3 and continuing until day 35 followed by a taper until day 56. Patients also receive oral mycophenolate mofetil three times daily on days 0-40.

Patients with stable mixed chimerism on day 56 and no evidence of graft-vs-host disease may receive escalating doses of nonmobilized T-cell donor lymphocyte infusion (DLI) over 30 minutes. Patients may receive up to 4 DLIs if there is evidence of disease progression.

Patients are followed weekly for 3 months, monthly for 3 months, every 6 months for 2 years, and then annually for 3 years.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Brenda Sandmaier, MD, Protocol chair		Ph: 206-288-1024

Registry Information
Official Title		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
Trial Start Date		2000-02-23
Registered in ClinicalTrials.gov		NCT00005851
Date Submitted to PDQ		2000-04-10
Information Last Verified		2006-10-18
NCI Grant/Contract Number		CA78902, CA15704, CA106512

Back to Top