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Exploratory Study of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy

Phase 2
10 Years
80 Years
Open (Enrolling)
Breast Cancer, Carcinoma of Unknown Primary, Colorectal Cancer, Esophageal Cancer, Gallbladder Cancer, Gastric Cancer, Liver Cancer, Lung Cancer, Pancreatic Cancer, Prostate Cancer, Sarcoma

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Trial Information

Exploratory Study of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy



- Identify an anti-tumor effect of allogeneic peripheral blood stem cell transplantation
by induction of a graft-versus-tumor effect in patients with a diversity of metastatic
solid tumors refractory to standard therapy.


- Determine engraftment in these patients.

- Determine the effects of donor lymphocyte infusion and cyclosporine withdrawal on tumor
regression in these patients.

OUTLINE: Patients are stratified according to risk of graft rejection, which determines the
preparative regimen received. High-risk patients include heavily transfused patients or
patients who have received donor-directed blood products and single HLA-locus mismatched

Preparative regimen: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and
fludarabine IV over 30 minutes on days -5 to -1. Patients at high risk also receive
antithymocyte globulin IV on days -5 to -2.

Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients
receive cyclosporine either by continuous infusion IV or orally twice a day on days -4 to
100 as graft-versus-host disease (GVHD) prophylaxis.

Patients with less than 100% donor T-cell chimerism or with evidence of tumor progression
receive donor lymphocytes after day 100, every 4 weeks, until 100% donor T-cell chimerism,
disease regression, and/or GVHD occurs.

Patients are followed at 4, 6, 8, 10, and 12 months, every 3 months for 2 years, and then
every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 150 patients (10 for each cancer) will be accrued for this

Inclusion Criteria


- Histologically proven progressive and incurable metastatic solid tumors

- Hepatocellular carcinoma

- Pancreatic carcinoma

- Cholangiocarcinoma

- Esophageal carcinoma

- Gastric carcinoma

- Colon and rectal carcinoma

- Breast carcinoma

- Hormone-refractory prostate carcinoma

- Soft tissue sarcomas

- Bony sarcomas

- Refractory to standard therapy or no known curative therapy exists

- Bidimensionally evaluable metastatic disease by radiography

- HLA-identical or single HLA-locus mismatched family donor available

- No CNS metastases associated with intracranial bleeding, uncontrolled seizure
disorder, or significant intracranial mass effect

- Hormone receptor status:

- Not specified



- 10 to 80


- Not specified

Menopausal status:

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months


- Not specified


- Bilirubin no greater than 4 mg/dL

- SGOT/SGPT no greater than 5 times upper limit of normal


- Creatinine no greater than 2.5 mg/dL


- LVEF at least 30%


- DLCO at least 40% predicted


- Not pregnant or nursing

- No psychiatric disorder or severe mental deficiency

- No other major illness or organ failure

- Oral intake at least 1,200 calories/day

- No recent weight loss of 10% or more

- No other malignant diseases liable to relapse or progress within 5 years

- No uncontrolled infection


Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- Not specified


- Not specified


- Not specified


- At least 30 days since prior cancer therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Tumor response (i.e., complete response, partial response, stable disease, or progressive disease)

Safety Issue:


Principal Investigator

Richard W. Childs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • Carcinoma of Unknown Primary
  • Colorectal Cancer
  • Esophageal Cancer
  • Gallbladder Cancer
  • Gastric Cancer
  • Liver Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Sarcoma
  • stage IV colon cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • metastatic osteosarcoma
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • stage IV adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV childhood liver cancer
  • recurrent childhood liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • recurrent osteosarcoma
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • recurrent prostate cancer
  • childhood hepatocellular carcinoma
  • adult primary hepatocellular carcinoma
  • metastatic childhood soft tissue sarcoma
  • recurrent childhood soft tissue sarcoma
  • adenocarcinoma of unknown primary
  • cholangiocarcinoma of the gallbladder
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • stage IV prostate cancer
  • recurrent non-small cell lung cancer
  • stage IV pancreatic cancer
  • Breast Neoplasms
  • Carcinoma
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Gallbladder Neoplasms
  • Neoplasms, Unknown Primary
  • Sarcoma



NIH - Warren Grant Magnuson Clinical Center Bethesda, Maryland  20892-1182