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Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: May 6, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Colorado at Denver and Health Sciences Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00015912
  Purpose

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
Lymphoma
Biological: recombinant interferon alfa
Drug: thalidomide
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Thalidomide Interferon alfa-2a Interferon alfa-n1 Interferons
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2001
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of interferon alfa and thalidomide, in terms of response rate, time to progression, and overall survival, in patients with relapsed or refractory low-grade follicular non-Hodgkin's lymphoma.
  • Determine the quantitative and qualitative toxic effects of this regimen in this patient population.
  • Correlate ancillary biological studies with clinical endpoints in these patients treated with this regimen.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed relapsed or refractory low-grade follicular non-Hodgkin's lymphoma (NHL)

    • WHO grade 1 or 2
    • Failure to achieve a complete or partial remission after prior treatment regimen OR
    • Relapse or disease progression within 30 days after prior treatment regimen
  • No histologic transformation to aggressive NHL or areas of diffuse NHL
  • At least 1 measurable lesion by CT scan, MRI, or chest x-ray
  • Tissue in the form of tissue blocks available
  • No brain metastasis or primary brain tumors NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma.

However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8.5 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT/SGPT no greater than 2.5 times upper limit of normal
  • PT (or INR)/PTT normal or not clinically significant
  • No preexisting liver disease

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No uncompensated coronary artery disease
  • No myocardial infarction or severe/unstable angina within the past 6 months

Other:

  • No active infection
  • No prior gastrointestinal disorder that would interfere with thalidomide absorption
  • No preexisting autoimmune disease
  • No medical, psychological, or social problem that would preclude study participation
  • No uncontrolled or untreated depression
  • No emotional disorder or substance abuse
  • No prior seizures or potential risk factors for development of seizures
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test at baseline, weekly for 4 weeks, and then every 2-4 weeks thereafter while on study
  • Fertile female patients must use 1 highly active method and 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study
  • Fertile male patients must use effective barrier contraception during and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No more than 1 prior course of unconjugated monoclonal antibody therapy
  • No prior conjugated monoclonal antibody (radiolabeled or immunotoxin) therapy
  • No prior interferon alfa
  • No concurrent hematopoietic growth factors or other cytokines
  • No concurrent monoclonal antibodies

Chemotherapy:

  • No more than 2 prior chemotherapy regimens (single agent or combination)
  • At least 28 days since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 28 days since prior corticosteroid therapy
  • Prior or concurrent megestrol allowed
  • No concurrent corticosteroids
  • No concurrent hormonal therapy

Radiotherapy:

  • Prior palliative radiotherapy to nontarget lesions allowed
  • No prior radiotherapy to all sites of measurable disease
  • No prior extensive radiotherapy to more than 20% of bone marrow
  • No concurrent palliative radiotherapy

Surgery:

  • At least 14 days since prior major surgery
  • No prior major upper gastrointestinal surgery

Other:

  • No other concurrent cytotoxic agents
  • No other concurrent investigational therapy
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015912

Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Sponsors and Collaborators
University of Colorado at Denver and Health Sciences Center
Investigators
Study Chair: John W. Sweetenham, MD University of Colorado at Denver and Health Sciences Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009