Adult Hodgkin's Lymphoma |
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Clinical Trial: Interferon alfa-2b Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non- Hodgkin's Lymphoma
This study is no longer recruiting patients.
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Purpose
RATIONALE: Interferon-alfa may interfere with the growth of cancer cells. Giving interferon-alfa following chemotherapy and peripheral stem cell transplantation may be an effective treatment for Hodgkin's disease or non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa-2b following chemotherapy and stem cell transplantation in treating patients who have recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| recurrent diffuse small lymphocytic/marginal zone lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade III follicular large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma recurrent adult diffuse mixed cell lymphoma recurrent mantle cell lymphoma recurrent adult diffuse large cell lymphoma Waldenstrom's Macroglobulinemia recurrent adult Hodgkin's disease recurrent grade I follicular small cleaved cell lymphoma recurrent grade II follicular mixed cell lymphoma | Drug: interferon alfa | Phase III |
MedlinePlus related topics: Blood and Blood Disorders; Hodgkin's Disease; Immune System and Disorders; Lymphatic Diseases; Lymphoma; Vascular Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Interferon Alfa-2b Following High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma
Study start: October 1995
OBJECTIVES: I. Determine the efficacy of interferon alfa-2b in reducing the relapse rate in patients with recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma in second remission following high dose chemotherapy and autologous stem cell transplantation. II. Compare the time to disease progression and survival in this patient population treated with interferon alfa-2b vs no further treatment. III. Assess the tolerability of these treatment regimens in these patients.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymphoma subtype. Patients are randomized to one of two treatment arms. Arm I: Patients receive no further therapy following high dose chemotherapy and autologous stem cell transplantation. Arm II: Beginning 4 weeks after high dose chemotherapy and autologous stem cell transplantation, patients receive interferon alfa-2b subcutaneously three times a week. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study within 4-5 years.
Eligibility
Ages Eligible for Study: 18 Years - 64 Years
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically proven non-Hodgkin's lymphoma or Hodgkin's disease Diffuse small cell (i.e., chronic lymphocytic leukemia, small lymphocytic, immunocytoma); Follicular; Mantle cell; Peripheral T cell; Diffuse large B cell; Leukemic (i.e., lymphoblastic, Burkitt's)
- First relapse or first progression after responding to a salvage regimen and high dose chemotherapy with autologous stem cell transplantation (second remission); Response of greater than 50% of tumor mass decrease observed at time of progression
- Prior high dose chemotherapy plus autologous stem cell transplantation as first line therapy allowed
--Prior/Concurrent Therapy--
- Biologic therapy: See Disease Characteristics; No other concurrent immunotherapy; No concurrent hematopoietic growth factors
- Chemotherapy: See Disease Characteristics; No concurrent chemotherapy
- Endocrine therapy: Not specified
- Radiotherapy: No concurrent radiotherapy
- Surgery: Not specified
--Patient Characteristics--
- Age: 18 to 64
- Performance status: ECOG 0-2
- Life expectancy: Not specified
- Hematopoietic: Not specified
- Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminase no greater than 3.0 times upper limit of normal
- Renal: Creatinine no greater than 1.7 mg/dL
- Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other prior or concurrent malignancies except curatively treated (by radiotherapy or surgery) basal cell skin cancer or carcinoma in situ
Location Information
France
Hopital Jules Courmont - Centre Hospitalier Lyon Sud, Pierre-Benite, 69495, France
United Kingdom, England
Christie Hospital N.H.S. Trust, Manchester, England, M20 4BX, United Kingdom
Bertrand Coiffier, Study Chair, Groupe d'Etudes de Lymphomes de L'Adulte
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003924
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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