AzTrials
AzTrials

Recurrent Grade 1 Follicular LymphomaPhase 2NCT00015912

Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 2 study testing recombinant interferon alfa, thalidomide and laboratory biomarker analysis in people with Recurrent Grade 1 Follicular Lymphoma and Recurrent Grade 2 Follicular Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
recombinant interferon alfa, thalidomide and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Jul 2001to Sep 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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
Show all 54Show fewer
  • Tissue in the form of tissue blocks available
  • No brain metastasis or primary brain tumors
  • Performance status - ECOG 0-1
  • More than 3 months
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8.5 g/dL
  • 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
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance greater than 60 mL/min
  • No uncompensated coronary artery disease
  • No myocardial infarction or severe/unstable angina within the past 6 months
  • 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
  • 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
  • No more than 2 prior chemotherapy regimens (single agent or combination)
  • At least 28 days since prior chemotherapy
  • No concurrent chemotherapy
  • At least 28 days since prior corticosteroid therapy
  • Prior or concurrent megestrol allowed
  • No concurrent corticosteroids
  • No concurrent hormonal therapy
  • 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
  • At least 14 days since prior major surgery
  • No prior major upper gastrointestinal surgery
  • No other concurrent cytotoxic agents
  • No other concurrent investigational therapy
  • No other concurrent anticancer therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado

    Denver, Colorado, 80217-3364

Other trials in United States

About this study

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

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. 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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

II. Determine the quantitative and qualitative toxic effects of this regimen in this patient population.

III. 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.

Being tested
recombinant interferon alfa, thalidomide, laboratory biomarker analysis
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon alfaBiological

    Also called Alferon N, alpha interferon, IFN-A, Intron A

    Given IV

  • thalidomideDrug

    Also called Kevadon, Synovir, THAL, Thalomid

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00015912
Study groupRoleWhat they receive
Treatment (interferon-alpha, thalidomide)ExperimentalPatients receive interferon alfa subcutaneously every 12 hours and oral thalidomide daily in the absence of disease progression or unacceptable toxicity.
Receives: Biological: recombinant interferon alfa; Drug: thalidomide; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (complete and partial)

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Time to progression

    Kaplan-Meier estimates will be determined.

    Measured: Up to 2 years

  2. Overall survival

    Kaplan-Meier estimates will be determined.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2003 (estimated)
  2. Study startJul 2001
  3. Primary completionSep 2003

Why it stopped: Administratively complete.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00015912
Sponsor's protocol ID
NCI-2012-02379
Other IDs
00-171; CWRU 5Y99, CDR0000068572
Status last verified
Jan 2013
First submitted
6 May 2001
Last updated
25 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing recombinant interferon alfa, thalidomide and laboratory biomarker analysis in people with Recurrent Grade 1 Follicular Lymphoma and Recurrent Grade 2 Follicular Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 54 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (complete and partial) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00015912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013; AzTrials last refreshed its copy on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in