Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CALGB-50002 NCT00022581

Objectives

1. Determine the response rate and time to progression in patients with relapsed or refractory low-grade non-Hodgkin's lymphoma treated with thalidomide.
2. 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.

Entry 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.]

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)

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/mm³

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

Expected Enrollment

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

Outcomes

Response rate
Time to progression
Effect on microvessel density in bone marrow and basic fibroblast growth factor 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.

Smith SM, Grinblatt D, Johnson JL, et al.: Thalidomide has limited single-agent activity in relapsed or refractory indolent non-Hodgkin lymphomas: a phase II trial of the Cancer and Leukemia Group B. Br J Haematol 140 (3): 313-9, 2008.[PUBMED Abstract]

Grinblatt DL, Johnson J, Niedzwicki D, et al.: Phase II study of thalidomide in escalating doses for follicular (F-NHL) and small lymphocytic lymphoma (Sll): CALGB study 50002. [Abstract] Blood 104 (11): A-3284, 2004.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

David Grinblatt, MD, Protocol chair		Ph: 847-570-2510; 888-909-5222 Email: dgrinblatt@enh.org

Registry Information
Official Title		A Phase II Trial of Thalidomide (NSC# 66847, IND# 48832) for Patients with Relapsed or Refractory Low Grade Non-Hodgkin's Lymphoma
Trial Start Date		2001-07-15
Trial Completion Date		2007-10-02
Registered in ClinicalTrials.gov		NCT00022581
Date Submitted to PDQ		2001-06-27
Information Last Verified		2009-06-27
NCI Grant/Contract Number		U10-CA31946

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