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

Phase 2
18 Years
Not Enrolling
Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Small Lymphocytic Lymphoma

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Trial Information

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


I. 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.


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.

Inclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate defined as complete + partial response

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

David Grinblatt

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

July 2001

Completion Date:

Related Keywords:

  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



Cancer and Leukemia Group B (CALGB) Research Base Chicago, Illinois  60604-1104