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Sponsors and Collaborators: |
University of Colorado at Denver and Health Sciences Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00015912 |
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of cancer cells.
Combining thalidomide with interferon alfa may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with interferon alfa in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: recombinant interferon alfa Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Clinical And Biologic Study Of The Combination Of Low Dose Interferon-Alpha And Thalidomide (NSC #66847) For Patients With Relapsed Or Refractory Low-Grade Follicular Lymphoma |
Study Start Date: | July 2001 |
OBJECTIVES:
OUTLINE: Patients receive interferon alfa subcutaneously every 12 hours and oral thalidomide daily in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 4-8 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed relapsed or refractory low-grade follicular non-Hodgkin's lymphoma (NHL)
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Colorado | |
University of Colorado Cancer Center | |
Denver, Colorado, United States, 80010 |
Study Chair: | John W. Sweetenham, MD | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | CDR0000068572, UCHSC-00171, NCI-590 |
Study First Received: | May 6, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00015912 History of Changes |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
Interferon-alpha Interferon Type I, Recombinant Immunoproliferative Disorders Immunologic Factors Thalidomide Interferons Lymphoma, Follicular Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents |
Follicular Lymphoma Recurrence Lymphoma, Small Cleaved-cell, Diffuse Anti-Bacterial Agents Lymphatic Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Interferon Alfa-2a Lymphoma |
Anti-Infective Agents Interferon Type I, Recombinant Thalidomide Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Lymphoma, Follicular Anti-Bacterial Agents Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Lymphoma Interferon-alpha Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Growth Substances Interferons Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Lymphatic Diseases Neoplasms Interferon Alfa-2a Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Leprostatic Agents |