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

Alternate Title

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	60 and under	NCI	CALGB-90003 ECOG-CALGB-C90003, SWOG-CALGB-C90003, NCT00027573

Objectives

1. 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.
2. Determine the toxicity and treatment-related mortality of this regimen in these patients.
3. Determine the percentage of donor chimerism in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• No concurrent sargramostim (GM-CSF)
• Concurrent epoetin alfa allowed

Chemotherapy:

• 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)

Radiotherapy:

• At least 14 days since prior radiotherapy

Surgery:

• At least 14 days since prior surgery

Other:

• At least 28 days since prior systemic therapy for RCC
• Recovered from prior therapy

Patient Characteristics:

Age:

• 60 and under

Performance status:

• ECOG 0-1

Life expectancy:

• More than 6 months

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST no greater than 3 times ULN

Renal:

• Creatinine clearance at least 40 mL/min

Cardiovascular:

• LVEF at least 45% by MUGA or echocardiogram

Pulmonary:

• DLCO greater than 40% of predicted (corrected for hemoglobin level)
• No symptomatic pulmonary disease

Other:

• 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

Expected Enrollment

A total of 36 patients will be accrued for this study within 18-24 months.

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 infusions.

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.

Rini BI, Halabi S, Barrier R, et al.: Adoptive immunotherapy by allogeneic stem cell transplantation for metastatic renal cell carcinoma: a CALGB intergroup phase II study. Biol Blood Marrow Transplant 12 (7): 778-85, 2006.[PUBMED Abstract]

Rini BI, Halabi S, Barrier R, et al.: CALGB 90003: adoptive immunotherapy by allogeneic stem cell transplantation for metastatic renal cell carcinoma: an intergroup phase II study. [Abstract] Blood 104 (11): A-810, 2004.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Brian Rini, MD, Protocol chair(Contact information may not be current)		Ph: 415-353-7095; 800-888-8664 Email: brini@medicine.ucsf.edu

Southwest Oncology Group

Clinical Trials Office - New Patient Services		Ph: 800-826-4673 Email: becomingapatient@coh.org

Eastern Cooperative Oncology Group

David Avigan, MD, Protocol chair		Ph: 617-667-9920

Registry Information
Official Title		Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study
Trial Start Date		2001-10-15
Registered in ClinicalTrials.gov		NCT00027573
Date Submitted to PDQ		2001-10-04
Information Last Verified		2004-04-26
NCI Grant/Contract Number		CA31946

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