Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004135
• Other study ID #: 9672
• Secondary ID: UCCRC-9672UCCRC-
• Status: Completed
• Phase: Phase 2
• First received: December 10, 1999
• Last updated: March 6, 2014
• Start date: February 1999
• Est. completion date: August 2007

Study information

• Verified date: March 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic kidney cancer or melanoma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2007
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• filgrastim

• therapeutic allogeneic lymphocytes

Drug:
• cyclophosphamide

• fludarabine phosphate

Procedure:
• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate		3 years	No