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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Todd Zimmerman, University of Chicago
ClinicalTrials.gov Identifier:
NCT00004135
First received: December 10, 1999
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Melanoma (Skin)
 Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Complete Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: February 1999
Study Completion Date: August 2007
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Fludarabine 30 mg/m2/d x S days IVPB in 100 cc NS over 30 minutes on day -8, -7, -6, -S, and -4. Cyclophosphamide 2 gm/m2/d x 2 days IVPB in SOO cc DS W over I hour on day -3 and day-2. G-CSF (Neupogen®) administration 480 f!gld subcutaneously starting on day +5 (or first day of neutropenia if earlier)and continued until an ANC of 0.5 x 109/L is maintained for 3 consecutive days.
 Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004135

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Investigators
Study Chair: Todd M. Zimmerman, MD University of Chicago
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Todd Zimmerman, Associate Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT00004135     History of Changes
Other Study ID Numbers: 9672, UCCRC-9672, UCCRC-CTRC-9866, NCI-G99-1612
Study First Received: December 10, 1999
Last Updated: February 7, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
stage IV renal cell cancer
recurrent renal cell cancer
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Melanoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cyclophosphamide
Fludarabine monophosphate
Fludarabine
Lenograstim
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on May 19, 2013