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	Active	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

U.S.A.
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Kokomo
	Howard Community Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend Clinic
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Kansas
	Overland Park
	Menorah Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Shawnee Mission
	Shawnee Mission Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
Michigan
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Missouri
	Independence
	Independence Regional Health Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	North Kansas City Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parvin Radiation Oncology
		Rakesh Gaur, MD	Ph:  816-823-0555
	Research Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Luke's Cancer Institute at Saint Luke's Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	St. Joseph Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Truman Medical Center - Hospital Hill
		Rakesh Gaur, MD	Ph:  816-823-0555
	Lee's Summit
	Saint Luke's East - Lee's Summit
		Rakesh Gaur, MD	Ph:  816-823-0555
	Liberty
	Liberty Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Joseph
	Heartland Regional Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Nancy Bartlett, MD	Ph:  314-362-5654

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

Back to Top