Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors: A Phase I Study


Phase 1
N/A
59 Years
Not Enrolling
Both
Breast Cancer, Kidney Cancer, Lung Cancer, Cutaneous Melanoma, Testicular Germ Cell Tumor

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Trial Information

Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors: A Phase I Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard K. Burt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 99H2

NCT ID:

NCT00006126

Start Date:

September 1999

Completion Date:

April 2001

Related Keywords:

  • Breast Cancer
  • Kidney Cancer
  • Lung Cancer
  • Cutaneous Melanoma
  • Testicular Germ Cell Tumor
  • 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
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Lung Neoplasms
  • Melanoma
  • Skin Neoplasms
  • Neoplasms, Germ Cell and Embryonal

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