Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Thalidomide may stop the growth of non-Hodgkin's lymphoma by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed or refractory low-grade non-Hodgkin's lymphoma.

Further Study Information

OBJECTIVES:

• Determine the response rate and time to progression in patients with relapsed or refractory low-grade non-Hodgkin's lymphoma treated with thalidomide.

• Determine the effect of this drug on microvessel density in bone marrow and basic fibroblast growth factor levels in serum and urine in these patients.

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed relapsed or refractory low-grade non-Hodgkin's lymphoma of 1 of the following subtypes:

• Follicular grades I, II, or III

• B-cell small lymphocytic lymphoma

• Bidimensionally measurable disease

• Greater than 1 cm in each dimension by physical exam, x-ray, MRI, or CT scan

• The following are not considered measurable:

• Barium studies

• Ascites or pleural effusions

• Bony disease

• Bone marrow

• No marginal zone lymphoma

• No known lymphomatous involvement of the CNS, including parenchymal or leptomeningeal involvement 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 OR

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 750/mm^3

Hepatic:

• Bilirubin normal

• AST and ALT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2 times normal

Neurologic:

• No seizure disorders

• No prior brain injury that would precipitate seizures

• No peripheral neuropathy greater than grade 1

Other:

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Regardless of fertility status:

• Female patients must use at least 1 highly active method of contraception AND 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study participation

• Male patients must use effective barrier contraception during and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No more than 2 prior antibody treatments

Chemotherapy:

• No more than 3 prior chemotherapy regimens

• No concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)

• No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent bisphosphonates (e.g., zoledronate)

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

David L. Grinblatt

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00022581
Information obtained from ClinicalTrials.gov on December 14, 2011

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