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Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Biological Therapy in Treating Patients With Solid Tumors or Lymphoma
This study has been completed.
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027937
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Biological therapies such as interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have solid tumors or lymphoma.


Condition Intervention Phase
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: aldesleukin
Drug: busulfan
Drug: cyclophosphamide
Drug: filgrastim
Drug: melphalan
Drug: paclitaxel
Drug: sargramostim
Drug: thiotepa
Procedure: bone marrow ablation with stem cell support
Procedure: in vitro-treated peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma
Drug Information available for: Cyclophosphamide Filgrastim Melphalan Thiotepa Aldesleukin Paclitaxel Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor Melphalan hydrochloride Sarcolysin Busulfan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Mobilization Chemotherapy With GMCSF And GCSF Followed By High Dose Therapy Combined With IL2 Activated Autologous Peripheral Blood Stem Cells Followed By Sequential IL2 Therapy As Treatment For Solid Tumors And Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2001
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the toxicity of sargramostim (GM-CSF) and filgrastim (G-CSF)-mobilized interleukin-2(IL-2)-incubated autologous peripheral blood stem cells and sequential IL-2 in patients with solid tumors or lymphoma.
  • Determine the ability of cyclophosphamide and paclitaxel followed by GM-CSF and G-CSF to mobilize adequate numbers of CD34+ cells and immune cells in these patients.
  • Determine the time to neutrophil and platelet engraftment in patients treated with this regimen.
  • Determine the overall and disease-free survival of patients treated with this regimen.

OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) alone on days 3-9 and GM-CSF and filgrastim (G-CSF) SC beginning on day 10 and continuing until leukapheresis is completed.

Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -8 to -6, melphalan IV on days -5 and -4, and thiotepa IV on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are treated ex vivo with interleukin-2 (IL-2) on day -1. Patients undergo IL-2-treated autologous PBSC transplantation on day 0.

Beginning 4 hours after PBSC transplantation, patients receive IL-2 IV continuously for 5 days. IL-2 therapy repeats every 7 days for 4 courses.

Patients are followed on days 60-80, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   up to 56 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of solid tumor, Hodgkin's lymphoma, or B-cell non-Hodgkin's lymphoma
  • Eligible for autologous stem cell transplantation
  • No pleural effusion, pericardial effusion, or ascites
  • No T-cell lymphoma

PATIENT CHARACTERISTICS:

Age:

  • Under 57

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's disease)
  • SGOT or SGPT no greater than 2 times upper limit of normal
  • Hepatitis B and C negative

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • LVEF at least 50%
  • No congestive heart disease
  • No history of myocardial infarction within the past year
  • No coronary artery disease
  • No history of arrhythmia

Pulmonary:

  • Diffusion capacity (corrected) at least 60%
  • FEV_1 at least 65% of predicted

Other:

  • HIV negative
  • No history of seizures
  • No mental disorders requiring medication (e.g., haloperidol)
  • No active connective tissue disease
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or any carcinoma in situ
  • No allergy to gentamicin
  • No hypersensitivity to E. coli-derived preparations
  • No history of severe allergy to sargramostim (GM-CSF) or filgrastim (G-CSF)
  • No systemic infection
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent corticosteroid therapy

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No contrast dye for 3 weeks after completion of interleukin-2 therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027937

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

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

Study ID Numbers: CDR0000069095, FHCRC-1595.00, IMMUNEX-FHCRC-1595.00, NCI-G01-2037
Study First Received: December 7, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00027937  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
unspecified childhood solid tumor, protocol specific
unspecified adult solid tumor, protocol specific
stage II childhood Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I adult Burkitt lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma

Study placed in the following topic categories:
Melphalan
Hodgkin's disease
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Cyclophosphamide
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Lymphoma, B-Cell
Lymphoma, large-cell
Burkitt's lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Hodgkin Disease
Lymphoma
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoblastic lymphoma
Mantle cell lymphoma
Recurrence
Thiotepa
Lymphatic Diseases
Aldesleukin
Paclitaxel
Busulfan
Burkitt Lymphoma

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009