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Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study

Phase 2
60 Years
Not Enrolling
Kidney Cancer

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Trial Information

Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study


- Determine the overall response rate and overall and disease-free survival of patients
with unresectable or metastatic renal cell cancer treated with fludarabine and
cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation.

- Determine the toxicity and treatment-related mortality of this regimen in these

- Determine the percentage of donor chimerism in patients treated with this regimen.

OUTLINE: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and
cyclophosphamide IV over 1-2 hours on days -4 and -3. Allogeneic peripheral blood stem cells
are infused on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily
beginning on day 5 and continuing until blood counts recover.

Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral tacrolimus
twice daily on days -1 to 90 and methotrexate IV on days 1, 3, and 6.

After day 120, patients with persistent disease and no signs of active GVHD may receive
donor lymphocyte infusion (DLI). DLI may be repeated every 8 weeks for a total of 2

Patients are followed every 2 months for 1 year and then every 6 months for 4 years OR every
2 months for 6 months and then every 6 months for 4.5 years if patient receives DLI.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18-24

Inclusion Criteria


- Histologically confirmed renal cell carcinoma (RCC)

- Clear cell or papillary RCC

- Granular tumors with sarcomatoid features

- No purely sarcomatoid RCC, chromophobic RCC, or oncocytoma

- No transitional cell carcinoma of the renal pelvis and collecting systems

- Metastatic or unresectable disease

- At least 1 measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- The following are not considered measurable:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Primary bladder masses

- Progressive disease after interferon alfa and/or interleukin-2 for metastatic RCC OR
intolerance to these therapies

- No prior or concurrent CNS metastases

- Negative MRI of the brain within the past 28 days

- Must have HLA-identical (6/6) sibling donor



- 60 and under

Performance status:

- ECOG 0-1

Life expectancy:

- More than 6 months


- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST no greater than 3 times ULN


- Creatinine clearance at least 40 mL/min


- LVEF at least 45% by MUGA or echocardiogram


- DLCO greater than 40% of predicted (corrected for hemoglobin level)

- No symptomatic pulmonary disease


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No known hypersensitivity to E. coli-derived products

- No uncontrolled diabetes mellitus

- No active serious infection

- No other concurrent malignancy except non-melanoma skin cancer or other malignancy
that has less than a 30% risk of relapse after completion of therapy


Biologic therapy:

- See Disease Characteristics

- No concurrent sargramostim (GM-CSF)

- Concurrent epoetin alfa allowed


- No other concurrent chemotherapy

Endocrine therapy:

- At least 28 days since prior hormonal therapy (e.g., megestrol, corticosteroids, or
anti-estrogen therapy)

- Concurrent steroids allowed for adrenal failure, graft-versus-host disease, or other
nondisease-related conditions (e.g., insulin for diabetes)


- At least 14 days since prior radiotherapy


- At least 14 days since prior surgery


- At least 28 days since prior systemic therapy for RCC

- Recovered from prior therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian I. Rini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

Related Keywords:

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



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Northern New Jersey Hackensack, New Jersey  07601
CCOP - Oklahoma Tulsa, Oklahoma  74136
CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale, Arizona  85259