Skip to content

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00027573
Enrollment
36
Registered
2003-01-27
Start date
2001-10-31
Completion date
2006-06-30
Last updated
2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma, papillary renal cell carcinoma

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALfilgrastim
BIOLOGICALtherapeutic allogeneic lymphocytes
DRUGcyclophosphamide
DRUGfludarabine phosphate
DRUGmethotrexate
DRUGtacrolimus
PROCEDUREperipheral blood stem cell transplantation

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 60 Years
Healthy volunteers
No

Inclusion 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 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

Design outcomes

Primary

MeasureTime frame
Overall response rateUp to 5 years
Overall survivalUp to 5 years
Disease-free survivalUp to 5 years
Treatment-related mortalityUp to 5 years
Percentage of donor chimerism in patients treatedUp to 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026