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Recurrent Grade 1 Follicular LymphomaPhase 2NCT00022581

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

A Phase 2 study testing 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed or refractory low-grade non-Hodgkin's lymphoma. Thalidomide may stop the growth of non-Hodgkin's lymphoma by stopping blood flow to the tumor Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
thalidomide and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
Jul 2001to Dec 2004
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 documented non-Hodgkin's lymphoma; core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable for follicular lymphomas; patients with NHL must have one of the following World Health Organization (WHO) histologic subtypes:
  • Follicular, grade 1
  • Follicular, grade 2
  • Follicular, grade 3
  • B-cell small lymphocytic lymphoma
  • Note: Patients diagnosed more than one year prior to entry on protocol must have a repeat lymph node biopsy; in the event of rapid tumor growth, rising LDH, or the onset of B symptoms in a period of time less than one year a rebiopsy is also required; patients are ineligible for this study if a separate lymph node biopsy shows a lymphoma with a higher grade; failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible
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  • No known lymphomatous involvement of the CNS including either parenchymal or leptomeningeal involvement (lumbar puncture prior to study is not required in the absence of neurologic symptoms) or any seizure disorders or prior brain injury which could precipitate seizures
  • Measurable disease must be present either on physical examination or imaging studies; evaluable disease alone is not acceptable; any tumor mass reproducibly measurable in two perpendicular diameters and > 1x1 cm by physical examination, X-ray, computerized tomography (CT), or magnetic resonance imaging (MRI) is acceptable; whenever CT is specified, it should be understood that MRI may be substituted as long as the measurements for tumor response are made on two successive studies employing the same procedure; the following lesions are not considered measurable:
  • Barium studies
  • Ascites or pleural effusion
  • Bony disease (lesions if present should be noted)
  • Bone marrow
  • Patients must have received no more than 3 prior chemotherapy regimens and no more than 2 prior antibody treatments; patients who have failed to respond to 3 regimens of prior chemotherapy (i.e., refractory to 3 regimens) are not eligible
  • NCI CTC performance status of 0 or 1
  • Pregnant and nursing women are not eligible for treatment on this protocol; women of childbearing potential must agree to abstain from all intercourse or use two methods of birth control for 28 days prior to treatment and while under treatment with thalidomide and for four weeks after completing therapy; one of the methods of birth control must be highly active (IUD, hormonal, tubal ligation or partner's vasectomy) and used concomitantly with one additional method (e.g., latex condom, diaphragm or cervical cap); these precautions are required even in patients with a history of infertility unless due to hysterectomy or because the patient has been post menopausal or has had no menses for at least 24 consecutive months; in addition, women of childbearing potential must have serum B-HCG performed prior to treatment, weekly for the first 4 weeks of treatment and then every four weeks if menses are regular and every two weeks if menses are irregular; men must agree to abstain from unprotected sexual intercourse; male patients should request that female partners use a second method of birth control in addition to the male barrier method
  • No known HIV disease; patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus; because peripheral neuropathies are a common toxicity of antiviral therapy and of viral infection in HIV patients, as well as a common significant toxicity with thalidomide, patients who test positive or who are known to be infected are not eligible; an HIV test is not required for entry on protocol, but is required if the patient is perceived to be at risk
  • No peripheral neuropathy > grade 1
  • Patients requiring the use of bisphosphonates (e.g., zoledronic acid) are not eligible; patients who receive thalidomide in combination with zoledronic acid are potentially at increased risk of renal dysfunction; patients enrolled on study prior to 15 September 2003 who are receiving bisphosphonates may continue to receive thalidomide and bisphosphonate but must have serum creatinine monitored prior to each bisphonate infusion; in addition, please inform these patients of the potential for renal dysfunction with this combination; this discussion must be documented in the patient record
  • ANC ≥ 750/μL
  • βHCG negative (in female patients unless S/P hysterectomy or menopausal or no menses for 24 consecutive months); assay must have a sensitivity of at least 50 mIU/mL
  • Creatinine ≤ 2 x normal
  • Bilirubin ≤ within institutional normal limits
  • AST and ALT ≤ 2.5 x upper limit of normal

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer and Leukemia Group B (CALGB) Research Base

    Chicago, Illinois, 60604-1104

Other trials in United States

About this study

Official title: A Phase II Trial of Thalidomide (NSC #66847, IND #48832) for Patients With Relapsed or Refractory Low Grade Non-Hodgkin's Lymphoma

Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed or refractory low-grade non-Hodgkin's lymphoma. Thalidomide may stop the growth of non-Hodgkin's lymphoma by stopping blood flow to the tumor

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the response rate and time-to-progression (TTP) in previously treated patients with low grade non-Hodgkin's lymphoma treated with thalidomide.

II. To evaluate the effect of thalidomide on microvascular density in the bone marrow of patients with low grade cell non-Hodgkin's lymphoma.

III. To evaluate the effects of thalidomide on bFGF levels in serum and urine.

OUTLINE:

Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study.

Being tested
thalidomide, laboratory biomarker analysis
Medical subject headings
Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • thalidomideDrug

    Also called Kevadon, Synovir, THAL, Thalomid

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00022581
Study groupRoleWhat they receive
Treatment (thalidomide)ExperimentalPatients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: 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 defined as complete + partial response

    Measured: Up to 5 years

  2. Time to progression

    Estimated using the method of Kaplan and Meier using a two-sided significance level α=0.05.

    Measured: Time of patient registration until documented response, assessed up to 5 years

  3. Mean detectable difference in microvessel density (MVD) in patients treated with thalidomide

    The biserial correlation estimate will be used to measure the correlation between MVD and tenascin levels pre and post chemotherapy.

    Measured: Up to 6 months

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2001
  3. Primary completionDec 2004

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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022581
Sponsor's protocol ID
NCI-2012-03081
Other IDs
CALGB-50002, U10CA031946, CDR0000068832
Status last verified
Jan 2013
First submitted
10 Aug 2001
Last updated
7 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 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 23 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: finished, as of the sponsor's last update on 7 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 defined as complete + partial response (time frame: Up to 5 years). The study lists 3 primary outcomes in all. 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 NCT00022581.

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 7 Jan 2013.

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