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

NCT00022581 | Completed Phase 2

• 4 other identifiers: NCI-2012-03081CALGB-50002U10CA031946CDR0000068832
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (3)

• Response rate defined as complete + partial response

  Up to 5 years

• Time to progression

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

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

• 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.

  Up to 6 months

Study Arms (1)

Treatment (thalidomide)

EXPERIMENTAL

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

Drug: thalidomide; Other: laboratory biomarker analysis

Interventions

thalidomide DRUG

Given orally

Also known as: Kevadon, Synovir, THAL, Thalomid

Treatment (thalidomide)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (thalidomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B (CALGB) Research Base

Chicago, Illinois, 60604-1104, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David Grinblatt

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Primary Completion: December 1, 2004
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

US (1)