NCT Number: NCT00027573
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have metastatic or unresectable kidney cancer.
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Notify MeKey information
Conditions
Age range
Up to 60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, United States
About this study
OBJECTIVES:
- 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 patients.
- Determine the percentage of donor chimerism in patients treated with this regimen.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
PATIENT CHARACTERISTICS:
Age:
- 60 and under
Performance status:
- ECOG 0-1
Life expectancy:
- More than 6 months
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
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
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
Treatment and study plan
therapeutic allogeneic lymphocytes
BiologicalCyclophosphamide
Drugfludarabine phosphate
Drugmethotrexate
DrugTacrolimus
Drugperipheral blood stem cell transplantation
ProcedurePrimary outcomes
-
Overall response rate
Time frame: Up to 5 years
-
Overall survival
Time frame: Up to 5 years
-
Disease-free survival
Time frame: Up to 5 years
-
Treatment-related mortality
Time frame: Up to 5 years
-
Percentage of donor chimerism in patients treated
Time frame: Up to 5 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study
Important dates
- Study start
- 2001
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Jan 27, 2003
- Registry last updated
- Jul 14, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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