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Stem Cell Transplantation for Metastatic Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001880
First Posted: November 4, 1999
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
  Purpose

The goal of this research study is to identify other types of cancer (malignant neoplasms) that may be treatable with stem cell transplantation (allogenic peripheral blood stem cell transplantation.

Patients with a variety of different types of cancerous tumors that have spread (metastasized) and whose conditions have not improved with stand therapy, will be eligible to participate. Those patients selected to participate in the study will undergo a procedure known as a "mini-transplant". The mini-transplant is a transplantation of stem-cells collected from a sibling (brother or sister) of the patient. Unlike traditional bone marrow transplants, the mini-transplant does not require intense chemotherapy or radiation therapy. Because of this, patients experience fewer and less severe side effects.

This study is open to patients diagnosed with a variety of metastatic solid tumors including esophageal, gastric (stomach), colon, rectal, liver tumors (hepatoma), cancer of the biliary system (cholangiocarcinoma), cancer of the pancreas, lung, breast, prostate, bone (sarcoma), adrenal basal cell, bladder, and adenocarcinomas of unk primary origin....


Condition
Cholangiocarcinoma Colon/Rectal Ca Bladder Ca Breast Ca Esophageal/Gastric Ca Hepatocellular Ca Ovarian Ca Prostate Ca Pancreatic Ca Bony/Soft Tissue Sarcoma

Study Type: Observational
Official Title: Exploratory Study of Non-Myeloablative Allogeneic Stem Cell Transplantation and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

Primary Outcome Measures:
  • To identify an anti-tumor effect of allogeneic PBSC transplantation by induction of a graft-versus-tumor (GVT) effect in patients with a diversity of metastatic solid tumors, which are refractory to standard therapy.

Secondary Outcome Measures:
  • To evaluate engraftment by bone marrow and blood chimerism analysis.

Enrollment: 84
Study Start Date: March 12, 1999
Detailed Description:

The main objective of this study is to identify metastatic neoplasms, which may be susceptible to the GVT effect. We will treat patients with progressive metastatic solid tumors refractory to standard therapy with a non-myeloablative allogeneic PBSC transplant from a family donor. A GVT effect from immunocompetent donor immune cells could extend life expectancy and possibly cure such patients.

Eligible patients will be treated with an allogeneic peripheral blood stem cell transplant from an HLA identical or single HLA antigen-mismatched family donor, using an intensive immunosuppressive regimen without myeloablation ("mini-transplant") in an attempt to decrease the transplant related toxicities while preserving the anti-malignancy and/or anti-host marrow effect of the graft. The low intensity non-myeloablative conditioning regimen should provide adequate immunosuppression to allow stem cell and lymphocyte engraftment. A T-cell replete, donor-derived, granulocyte colony stimulating factor (G-CSF)-mobilized peripheral blood stem cells (PBSC) will be used to establish hematopoietic and lymphoid reconstitution. We will infuse lymphocytes in patients with <100% donor T-cell chimerism or with evidence of tumor progression in an attempt to prevent graft rejection and enhance a graft-versus-malignancy effect, respectively.

This trial is open to several different types of metastatic, treatment-refractory, solid neoplasms, breast, cholangiocarcinoma, small intestine/colon/rectal adenocarcinoma, esophageal/gastric, hepatocellular, pancreatic, prostate, and bony/soft tissue sarcomas. The trial design permits up to 10 patients with a specific tumor type to be enrolled to screen for anti-tumor effects. A single complete response in a specific tumor type is an indication to exclude further patients with that diagnosis from the study. Subsequently, a new protocol which focuses on further defining a GVT effect in that disease category will be instituted.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

PATIENTS:

Patients with metastatic solid tumors ( breast, cholangiocarcinoma, small intestine/colon/rectal, adenocarcinoma, esophageal/gastric, hepatocellular, pancreatic, prostate, bony/soft tissue sarcomas, which are histologically confirmed, progressive and incurable.

Due to low accrual, effective 12/19/2006, patients with adrenal, basal cell, transitional cell carcinoma of the bladder or uroepithelium, ovarian, small cell lung cancer, non small cell lung cancer, and adenocarcinomas of unknown primary origin are no longer eligible for the trial.

Age greater than or equal to 10 to less than or equal to 80.

No known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy.

Metastatic disease, which is bi-dimensionally evaluable radiographically.

No prior treatment for neoplasm within 30 days.

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Ability to comprehend the investigational nature of the study and provide informed consent.

Availability of HLA identical or single HLA-locus mismatched family donor.

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Willingness and availability to return to the NIH for scheduled follow-ups.

DONOR:

HLA identical or single HLA-locus mismatched family donor.

Age greater than or equal to 10 up to 80 years old.

Ability to comprehend the investigational nature of the study and provide informed consent.

EXCLUSION CRITERIA:

PATIENT:

Pregnant or lactating.

Age less than 10 or greater than 80 years.

ECOG performance status of 3 or more.

Psychiatric disorder or mental deficiency severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.

Major anticipated illness or organ failure incompatible with survival from PBSC transplant.

DLCO: less than 40% predicted.

Left ventricular ejection fraction: less than 30%.

Serum creatinine greater than 2.5mg/dl or creatinine clearance less than 50 cc/min by 24 hr urine collection.

Serum bilirubin greater than 4 mg/dl

Transaminases greater than 5 times the upper limit of normal.

Oral intake less than 1,200 calories/day.

Recent weight loss of greater than or equal to 10% of actual body weight.

Life expectancy less than 3 months

Therapy for malignancy within 4 weeks of beginning protocol.

CNS metastatic disease associated with intracranial bleeding, uncontrolled seizure disorder or significant intracranial mass effect.

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Other malignant diseases liable to relapse or progress within 5 years.

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Uncontrolled infection.

DONOR:

Pregnant or lactating.

Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of congestive heart failure or unstable angina, thrombocytopenia).

Age less than 10 or greater than 80 years.

HIV positive. Donors who are positive for HBV, HCV or HTLV-I may be used at the discretion of the investigator following counseling and approval from the recipient.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001880


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Richard W Childs, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00001880     History of Changes
Obsolete Identifiers: NCT00003839
Other Study ID Numbers: 990064
99-H-0064
First Submitted: July 3, 2006
First Posted: November 4, 1999
Last Update Posted: October 19, 2017
Last Verified: August 18, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Graft-Versus-Tumor
Peripheral Blood Stem Cells
Non-Myeloablative Bone Marrow Transplantation
Metastatic Solid Tumors
Engraftment
Cyclophosphamide
Fludarabine
Donor Apheresis
Graft-Versus-Host Disease
Cancer
Tumor

Additional relevant MeSH terms:
Sarcoma
Cholangiocarcinoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial