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Completed

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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Key information

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

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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

filgrastim

Biological

therapeutic allogeneic lymphocytes

Biological

Cyclophosphamide

Drug

fludarabine phosphate

Drug

methotrexate

Drug

Tacrolimus

Drug

peripheral blood stem cell transplantation

Procedure

Primary outcomes

  1. Overall response rate

    Time frame: Up to 5 years

  2. Overall survival

    Time frame: Up to 5 years

  3. Disease-free survival

    Time frame: Up to 5 years

  4. Treatment-related mortality

    Time frame: Up to 5 years

  5. 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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