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Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy


Phase 2
18 Years
65 Years
Not Enrolling
Both
Kidney Cancer, Melanoma (Skin)

Thank you

Trial Information

Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy


OBJECTIVES:

- Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral
blood stem cell transplantation in patients with metastatic renal cell carcinoma or
melanoma.

- Determine the incidence and severity of all adverse events related to this treatment
regimen in this patient population.

- Determine the efficacy of this treatment regimen in terms of tumor regression, response
duration, progression free survival, and overall survival in these patients.

- Measure the resulting chimerism and immune reconstitution in these patients after this
treatment regimen and correlate with clinical response.

OUTLINE: Patients receive fludarabine IV over 30 minutes on days -8 through -4 and
cyclophosphamide IV over 1 hour on days -3 and -2. Immediately following each daily donor
leukapheresis, patients receive allogeneic peripheral blood stem cells (PBSC) IV over 15
minutes beginning on day 0 and continuing until the target cells are collected. Patients
receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood
counts recover.

If no graft versus host disease has developed within 4 weeks of allogeneic PBSC
transplantation, patients with disease progression or recurrence who have residual donor
hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes.
Patients may receive an additional course of donor T lymphocytes at the investigator's
discretion.

Patients are followed at days 30 and 100, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 10-38 patients will be accrued for this study within 2.5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic renal cell carcinoma or melanoma that is not
potentially curable by surgery

- Evaluable disease or bidimensionally measurable disease on physical examination,
chest x-ray, CT scan, or MRI

- Measurable disease by radiography must be reproducible

- Bony disease or effusions not measurable

- No active CNS disease currently receiving radiotherapy or steroids

- No effusion or ascites of more than 1 liter prior to drainage

- HLA 5/6 or 6/6 matched sibling donor available

- No known hypersensitivity to E. coli derived products

- No active infection

- No health condition that would preclude donation

PATIENT CHARACTERISTICS:

Age:

- 18 to 65

Performance status:

- CALGB 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 2.0 g/dL

- No active hepatitis

Renal:

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance greater than 50 mL/min

Cardiovascular:

- LVEF at least 50%

Pulmonary:

- DLCO at least 50% of predicted

Other:

- No active infection

- HIV negative

- No psychological problem that would preclude study compliance

- No known hypersensitivity to E. coli derived products

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 4 weeks since prior systemic chemotherapy

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete Response Rate

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Todd M. Zimmerman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

9672

NCT ID:

NCT00004135

Start Date:

February 1999

Completion Date:

August 2007

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • stage IV melanoma
  • recurrent melanoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637