Chemotherapy Plus Interferon Alfa Alone or With Radiation Therapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: cyclophosphamide (Drug); filgrastim (Drug); prednisone (Drug); recombinant interferon alfa (Drug); vincristine (Drug); autologous bone marrow transplantation (Procedure); bone marrow ablation with stem cell support (Procedure); peripheral blood stem cell transplantation (Procedure); radiation therapy (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: European Organization for Research and Treatment of Cancer Official(s) and/or principal investigator(s):
Anton Hagenbeek, MD, PhD, Study Chair, Affiliation: University Medical Center Utrecht
Robert Marcus, MD, Study Chair, Affiliation: Cambridge University Hospitals NHS Foundation Trust
Anton Hagenbeek, MD, PhD, Study Chair, Affiliation: University Medical Center Utrecht
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.
Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation
therapy and kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
followed by interferon alfa alone or combination chemotherapy plus radiation therapy and
peripheral stem cell transplantation in treating patients who have previously untreated stage
III or stage IV follicular non-Hodgkin's lymphoma.
Clinical Details
Official title: Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation Followed by Interferon-Alpha Maintenance Treatment Versus Interferon-Alpha Maintenance Treatment Alone After a Chemotherapy-Induced Remission in Patients With Stages III or IV Follicular Non-Hodgkin's Lymphoma. A Prospective, Randomized, Phase III Clinical Trial.
Study design: Treatment
Detailed description:
OBJECTIVES: I. Compare the progression free and overall survival, toxicity, and mortality of
marrow ablative chemo/radiotherapy in addition to peripheral blood stem cell transplantation
and interferon alfa maintenance therapy versus interferon alfa maintenance therapy alone in
patients with follicular non-Hodgkin's lymphoma.
OUTLINE: This is a randomized study. All patients receive 8 courses of
cyclophosphamide/vincristine/prednisone (CVP) chemotherapy. Cyclophosphamide and vincristine
IV are given on day 1, along with oral prednisone on days 1-5. Courses are repeated every 3
weeks. Patients are randomized to receive one of two treatments 4 weeks after completion of
CVP chemotherapy if a partial or complete response is achieved and there are less than 15%
monoclonal B-lymphocytes in the bone marrow. Patients randomized to arm I receive interferon
alfa subcutaneously 3 times per week for a maximum of 3 years. Patients randomized to arm II
receive cyclophosphamide IV followed by subcutaneous filgrastim (granulocyte
colony-stimulating factor; G-CSF). Leukapheresis begins after leukocyte, platelet, and CD34+
levels recover and lasts 3-4 hours on 2-3 consecutive days. If an insufficient number of stem
cells are collected from the peripheral blood, bone marrow harvesting is performed. After
stem cell collection, a conditioning regimen consisting of cyclophosphamide IV on days - 4 and - 3 and total body irradiation on day -1 is administered. Stem cells are infused on day 0. If
granulocyte and platelet counts recover within 8 weeks, patients receive interferon alfa
maintenance therapy as in arm I. Patients are followed every 4 months until death.
PROJECTED ACCRUAL: A total of 469 patients will be accrued for this study within 5 years.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Previously untreated follicular stage III or IV non-Hodgkin's
lymphoma At least one measurable mass
PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Alkaline phosphatase and bilirubin less
than 2. 5 times upper limit of normal (ULN) (unless clearly related to NHL) Renal:
Creatinine and BUN less than 2. 5 times ULN (unless clearly related to NHL) Cardiovascular:
No severe cardiac disease (e. g. severe heart failure requiring treatment or cardiac
ejection fraction less than 45%) Neurologic: No neurologic disease Pulmonary: No pulmonary
disease Other: Not pregnant No prior malignancies except nonmelanoma skin cancer or
carcinoma in situ of the cervix Not HIV positive No psychiatric or metabolic disease
PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent immunotherapeutic
drugs, chemotherapy, or radiotherapy
Locations and Contacts
Academisch Ziekenhuis Utrecht, Utrecht 3508 GA, Netherlands
Addenbrooke's NHS Trust, Cambridge, England CB2 2QQ, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 1997
Last updated: May 23, 2008
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