Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Biological Therapy in Treating Patients With Solid Tumors or Lymphoma
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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 |
Biological: aldesleukin Biological: filgrastim Biological: sargramostim Drug: busulfan Drug: cyclophosphamide Drug: melphalan Drug: paclitaxel Drug: thiotepa Procedure: bone marrow ablation with stem cell support Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Start Date: | August 2001 |
| Study Completion Date: | November 2007 |
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 |
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| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | Leona A. Holmberg, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00027937 History of Changes |
| Other Study ID Numbers: | 1595.00, FHCRC-1595.00, IMMUNEX-FHCRC-1595.00, NCI-G01-2037, CDR0000069095 |
| Study First Received: | December 7, 2001 |
| Last Updated: | May 12, 2010 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Busulfan Cyclophosphamide Melphalan Thiotepa Aldesleukin Paclitaxel |
Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on June 18, 2013