Protocol Number: 97-H-0196

Title:

A Phase II Study of HLA-Matched Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma as Adoptive Allogeneic Immunotherapy

Number:

97-H-0196

Summary:

Metastatic Renal Cell Carcinoma (RCC) is an uncontrolled growth of renal cells, the cells which normally exist in the kidney. These cancerous cells can spread (metastasize) from the original kidney tumor site to other organs such as the bones, lymph nodes, liver, lungs, and brain. Once these organs become involved, the uncontrolled growth of cells can lead to organ failure and death.

There are several treatments available for RCC that can be successful. However, once RCC has spread to other organs it is rarely curable. Surgery can be used to treat RCC, but in many patients the disease has spread too much to be removed by surgery.

Medical treatment with chemotherapy can be used to treat RCC, but it has been relatively unsuccessful for patients whose cancer has spread to other organs.

Bone marrow transplants (BMT) have been used to treat cancers of the blood and bone marrow. However, BMTs are usually combined with powerful doses of chemotherapy and radiation therapy. These additional treatments are associated with toxic side effects, often making BMTs too dangerous to attempt in many patients. The effectiveness of BMT on solid tumors, like RCC, has not been well studied.

Researchers are interested in learning more about the potential benefits of modified bone marrow transplant (allogenic stem cell transplantation) for patients with advanced renal cell cancer.

In this study researchers plan to treat patients with advanced RCC with transplanted stem cells from a genetically matched brother or sister. These stem cells are healthy cells collected from the bone marrow of the patient's relative. Once the stem cells are transplanted they help to make new blood cells. In addition, immune factors found in the transplant can work to destroy cancerous cells.

In order to avoid the toxic side effects normally associated with BMT, the stem cell transplant will be combined with low intensity chemotherapy. The majority of the cancer killing effect will be the responsibility of the stem cell transplant rather than the chemotherapy.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA - PATIENT:

Ages 18-80 years.

Biopsy proven metastatic RCC, not amenable to complete surgical resection, progressive bidimensionally evaluable clinically or radiographically.

No prior treatment for RCC within 30 days.

HIV negative.

ECOG performance status of 1 or less.

No major organ dysfunction precluding transplantation.

DLCO greater than or equal to 65% predicted.

Left ventricular ejection fraction greater than or equal to 40%.

HLA 6/6 or 5/6 matched family related donor available.

Ability to comprehend the investigational nature of the study and provide informed consent.

Durable power of attorney signed.

INCLUSION CRITERIA - DONOR:

HLA 6/6 or 5/6 matched family related donor.

Fit to receive G-CSF and give peripheral blood stem cells (normal blood counts, normotensive, no history of stroke).

Ability to comprehend the investigational nature of the study and provide informed consent.

Ages 18-80.

EXCLUSION CRITERIA (any of the following) - PATIENT:

Patient Pregnant.

Age greater than 80 or less than 18 years.

ECOG performance status of 2 or more. Psychiatric disorder or mental deficiency of the patient or donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.

Major anticipated illness or organ failure incompatible with survival from BMT where survival is considered insufficient to assess transplant outcome (i.e. less than 3 months).

DLCO less than 65% predicted.

Left ventricular ejection fraction less than 40%.

Serum creatinine greater than 2.5mg/dl or creatinine clearance less than 50 cc/min by 24 hour urine collection.

Serum bilirubin greater than 4 mg/dl, transaminases greater than 3 x upper limit of normal.

HIV positive.

History of other malignancies except basal cell or squamous carcinoma of the skin.

Disease which is limited and amenable to complete surgical resection.

Lack of evidence for progressive disease.

Disease which is not evaluable clinically or radiographically.

Evidence for CNS metastatic disease.

Disease involving greater than 25% of the liver radiographically.

Hypercalcemia (greater than 2.5 mmol/L).

EXCLUSION CRITERIA - DONOR:

Donor pregnant or lactating.

Donor HIV or HBsAg positive.

History of malignancy within 5 years except basal cell or squamous carcinoma of the skin.

Donor unfit to receive G-CSF and undergo apheresis (Uncontrolled hypertension, history of stroke, thrombocytopenia).

Special Instructions:

Currently Not Provided

Keywords:

Peripheral Blood Stem Cells

Metastatic Renal Cell Carcinoma

Nonmyeloablative Bone Marrow Transplantation

Mini-Transplant

Marrow Chimerism

Graft-Versus-Tumor/Renal Cell Carcinoma

Renal Cell Carcinoma and Immunotherapy

Allogeneic Bone Marrow Transplantation and Renal Cell Carcinoma

Donor Apheresis

Recruitment Keyword(s):

None

Condition(s):

Neoplasm Metastasis

Renal Cell Carcinoma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: Stem cell transplantation

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Renal cell carcinoma

Different susceptibilities of lymphokine activated killer cells among primary and metastatic renal cell carcinoma derived from the same patient

Recognition of human primary renal cell carcinoma by HLA-A2-restricted cytotoxic T-lymphocytes is mediated by shared epitopes and up-regulated by interferon-gamma

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