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Nonmyeloablative Allogeneic Stem Cell Transplantation for the Treatment of Solid

18 Years
60 Years
Open (Enrolling)
Metastatic Solid Tumor

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Trial Information

Nonmyeloablative Allogeneic Stem Cell Transplantation for the Treatment of Solid

The trial is a pilot study in which patients with metastatic solid tumors will undergo
non-myeloablative allogeneic hematopoietic stem cell transplantation. Patients whose
immunosuppressive therapy has been tapered off, are without GVHD, and have evidence of
residual or progressive disease will undergo DLI.

In recent years there have been attempts to harness the graft-versus-tumor effect of
allogeneic bone marrow transplant to treat patients with metastatic solid tumors.
Researchers at the NIH recently reported on 19 patients with refractory metastatic
renal-cell carcinoma who had suitable donors and received a preparative regimen of
cyclophosphamide and fludarabine followed by an infusion of a peripheral-blood stem-cell
allograft from an HLA-identical sibling or a sibling with a mismatch of a single HLA
antigen.49 They note that at the time of the last follow-up, 9 of the 19 patients were alive
287 to 831 days after transplantation (median follow-up: 402 days). Two had died of
transplantation-related causes and 8 of progressive disease. In 10 patients (53%) metastatic
disease regressed: 3 had a complete response, and 7 had a partial response. The patients who
had a complete response remained in remission 27, 25, and 16 months after transplantation.
Regression of metastases was delayed, occurring a median of 129 days after transplantation,
and often followed the withdrawal of cyclosporine and the establishment of complete donor
T-cell chimerism. They concluded that these results were consistent with a
graft-versus-tumor effect and that non-myeloablative allogeneic stem cell transplantation
can induce sustained regression of metastatic RCCA in patients who have had no response to
conventional immunotherapy.

Inclusion Criteria

Inclusion Criteria


- Candidates for this trial will be patients with metastatic solid tumors for whom no
standard therapy exists or who have evidence of measurable disease that is clearly
progressing following standard biologic therapy or chemotherapy for metastatic

- Patients must have a healthy family member who is HLA-identical to the recipient and
who is willing and able to receive a course of G-CSF and undergo 2- 4 daily

- Each patient must be willing to participate as a research subject and must sign an
informed consent form.

- Patients must be ambulatory with good performance status (ECOG 0 or 1; Karnofsky PS

- Patients must have adequate organ function as defined by:

1. WBC > 3000/mm3, plt > 100,000/mm3, and hemoglobin > 10gm/100ml

2. Serum creatinine < 1.8mg/dl or Cr clearance > 60cc/min.

3. Total bilirubin < 1.5mg/dl

4. No evidence of congestive heart failure, symptoms of coronary artery disease,
serious cardiac arrhythmias

5. LVEF ≥40% by echocardiogram or MUGA scan (Patients whose LVEF is between 40% and
50% will have their cyclophosphamide dose reduced by 25% to 45 mg/kg/d for 2
days (total dose of 90 mg/kg).)

6. FEV1 > 2.0 liters or > 75% of predicted for height and age.

- Patients must not be on systemic corticosteroids for intercurrent illness.

- Patients must be between 18 and 60 years of age. Patients over 60 will be accrued on
an individual basis with approval of BMT service attendings.

- Women of childbearing potential must have a negative pregnancy test and not become
pregnant while on treatment.


- Absence of hematologic or marrow function-related diseases that interfere with the
collection of sufficient numbers of normal progenitor cells.

- Absence of any medical condition that would pose a serious health risk to a patient
undergoing peripheral blood stem cell harvest.

- Negative HIV, HTLV-1, and hepatitis C serologies.

- Negative for hepatitis B surface antigen (NOTE: Donors who are hepatitis B surface
antibody and/or core antibody positive BUT hepatitis B surface antigen negative will
be considered for transplant.)

- The donor must be a blood relation. Any healthy family member will be considered for
marrow donation. Selection of a donor will be based on typing of HLA-A, B, DR loci
to be carried out on the recipient, siblings, parents and possibly other family
members such as aunts, uncles and cousins. A prospective related donor must be HLA
identical to the patient.

Exclusion Criteria:


- Patients with brain metastases, leptomeningeal disease or seizure. (NOTE: Patients
with a history of brain metastases must be 6 months from definitive therapy (i.e.
surgery or radiation) and have no evidence of disease or edema on brain CT scan or

- Female patients who are pregnant or breast-feeding

- ECOG performance status >1. (Karnofsky PS <80%) (See Appendix 1.)

- Left ventricular ejection fraction of < 40%.

- Active viral (e.g. chronic active hepatitis), bacterial or fungal infection.

- Patients seropositive for HIV, HTLV -1,

- Patients not providing informed consent.

- Patients with known hypersensitivity to E. coli-derived products.


- A positive HIV or HTLV-1 test or evidence of active/persistent viral hepatitis
infection will exclude the donor from participation in this study. Donors who are HIV
or HTLV-1 positive are ineligible because of the risk of transmission of virus during
peripheral blood stem cell transplantation. Presence of any medical condition that
would pose a serious health risk by undergoing peripheral blood stem cell harvest.
Known hypersensitivity to E. coli-derived products.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the percent 100-day survival of patients with metastatic solid tumors undergoing non-myeloablative allogeneic stem cell transplantation (SCT).

Outcome Time Frame:

100 days

Safety Issue:


Principal Investigator

David F McDermott, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2000

Completion Date:

November 2012

Related Keywords:

  • Metastatic Solid Tumor
  • Stem cell transplant
  • Non-myeloablative
  • Metastatic Solid Tumor
  • Donor Leukocyte Infusion
  • Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215