Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Biological Therapy in Treating Patients With Solid Tumors or Lymphoma
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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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.
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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.
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Determine the time to neutrophil and platelet engraftment in patients treated with this regimen.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of solid tumor, Hodgkin's lymphoma, or B-cell non-Hodgkin's lymphoma
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Eligible for autologous stem cell transplantation
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No pleural effusion, pericardial effusion, or ascites
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No T-cell lymphoma
PATIENT CHARACTERISTICS:
Age:
- Under 57
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
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Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's disease)
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SGOT or SGPT no greater than 2 times upper limit of normal
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Hepatitis B and C negative
Renal:
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Creatinine no greater than 2.0 mg/dL OR
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Creatinine clearance at least 60 mL/min
Cardiovascular:
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LVEF at least 50%
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No congestive heart disease
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No history of myocardial infarction within the past year
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No coronary artery disease
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No history of arrhythmia
Pulmonary:
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Diffusion capacity (corrected) at least 60%
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FEV_1 at least 65% of predicted
Other:
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HIV negative
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No history of seizures
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No mental disorders requiring medication (e.g., haloperidol)
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No active connective tissue disease
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No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or any carcinoma in situ
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No allergy to gentamicin
-
No hypersensitivity to E. coli-derived preparations
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No history of severe allergy to sargramostim (GM-CSF) or filgrastim (G-CSF)
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109-1024 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Leona A. Holmberg, MD, PhD, Fred Hutchinson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1595.00
- FHCRC-1595.00
- IMMUNEX-FHCRC-1595.00
- NCI-G01-2037
- CDR0000069095