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Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
This study has been completed.
First Received: August 3, 2000   Last Updated: February 6, 2009   History of Changes
Sponsor: Robert H. Lurie Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006126
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have melanoma or small cell lung, breast, testicular, or kidney cancer that is metastatic or that cannot be treated with surgery.


Condition Intervention Phase
Breast Cancer
Kidney Cancer
Lung Cancer
Melanoma (Skin)
Testicular Germ Cell Tumor
Drug: busulfan
Drug: cyclophosphamide
Drug: etoposide
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors: A Phase I Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1999
Detailed Description:

OBJECTIVES: I. Determine the toxicity of allogeneic peripheral blood stem cell transplantation in patients with metastatic or unresectable small cell lung cancer, breast cancer, testicular germ cell cancer, melanoma, or renal cell cancer. II. Determine the efficacy of this regimen in these patients.

OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously for 4 or 5 days prior to peripheral blood stem cell harvest. Patients are assigned to one of three conditioning regimens, depending on disease. Group A (small cell lung cancer): Patients receive cyclophosphamide IV over 1-2 hours on days -7 and -6, etoposide IV over 4 hours on day -5, and total body irradiation twice daily on days -4 to -1. Group B (breast cancer and testicular germ cell cancer): Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 14 doses. Patients then receive cyclophosphamide IV over 1-2 hours on days -3 and -2. Group C (renal cell cancer and melanoma): Patients receive fludarabine IV daily on days -8 to -4 and cyclophosphamide IV on days -3 and -2. All groups: Patients receive allogeneic peripheral blood stem cells IV over 10-20 minutes on day 0. Patients are followed weekly for 3 months, at 6 and 12 months, and then yearly for 5 years.

PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable solid tumor of one of the following types: Small cell lung cancer Extensive stage (disease outside the hemithorax) or relapsed Prior cytoreduction with platinum/etoposide regimen and/or taxane containing regimen Epithelial breast cancer Stage IV or relapsed disease Prior cytoreduction with adriamycin and/or taxane regimens Testicular germ cell cancer Failure to achieve complete remission with platinum based chemotherapy Relapsed disease with at least one salvage regimen Melanoma Metastatic disease that has failed at least one biologic response modifier such as interleukin-2 or interferon Relapsed disease involving a visceral organ Renal cell cancer Metastatic disease that has failed at least one biologic response modifier such as interleukin-2 or interferon Relapsed disease involving a visceral organ HLA matched or one antigen mismatched related donor available Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Under physiologic 60 Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL unless due to Gilbert's disease SGOT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No congestive heart failure LVEF at least 40% Pulmonary: DLCO at least 45% of predicted OR FEV1/FVC at least 50% of predicted Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy that would preclude study Surgery: See Disease Characteristics

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006126

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Richard K. Burt, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068146, NU-99H2, NCI-G00-1838
Study First Received: August 3, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006126     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
stage IV renal cell cancer
recurrent renal cell cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Antimetabolites
Thoracic Neoplasms
Anti-Infective Agents
Vidarabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Cyclophosphamide
Urologic Neoplasms
Melanoma
Neoplasms by Site
Urologic Diseases
Respiratory Tract Diseases
Lung Neoplasms
Kidney Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Kidney Diseases
Alkylating Agents
Etoposide
Breast Diseases
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Skin Diseases
Breast Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009