Non Hodgkin Lymphoma Clinical Trial

Interferon Alfa in Treating Children With HIV-Related Cancer

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating children with an HIV-related cancer including leukemia, non-Hodgkin's lymphoma, CNS lymphoma, or other solid tumors.

View Full Description

Full Description

OBJECTIVES:

Determine the complete response rate and one-year disease free survival of pediatric patients with HIV-related malignancies treated with interferon alfa.
Determine the toxicity of interferon alfa alone and in combination with antiretroviral therapy in these patients.

OUTLINE:

Induction: Patients receive interferon alfa subcutaneously (SC) daily on days 1-14. Patients with advanced stage III or IV undifferentiated lymphomas or B-cell acute lymphoblastic leukemia also receive hydrocortisone intrathecally (IT) combined with cytarabine IT on day 14.
Maintenance: Patients with stable or responding disease after completion of induction receive interferon alfa SC 3 times a week beginning on week 1. Treatment continues for a minimum of 4-12 weeks in the absence of disease progression or unacceptable toxicity. Patients who received IT therapy during induction receive the same IT therapy at 4, 8, and 12 weeks and then every 8 weeks thereafter.

Patients are followed every 6 months for 4 years and then annually for survival until entry on another POG protocol.

PROJECTED ACCRUAL: A total of 14-30 evaluable patients will be accrued for this study within 4.2 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically proven malignancy diagnosed at any time following confirmation of HIV-positivity, including the following:

Leukemia
Non-Hodgkin's lymphoma
CNS lymphoma
Other solid tumors
Measurable disease

Concurrent registration on protocol POG-9182 required

Confirmed HIV-positive by POG-9182 criteria
Required biology studies completed

PATIENT CHARACTERISTICS:

Age:

21 and under

Performance status:

Not specified

Life expectancy:

More than 4 weeks

Hematopoietic:

Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 100,000/mm^3 (unless bone marrow involvement present)

Hepatic:

See Disease Characteristics
Bilirubin less than 1.5 times normal
SGPT and SGOT less than 2 times normal (may discuss with Study Coordinator)

Renal:

Creatinine less than 1.5 mg/dL

Cardiovascular:

Adequate cardiac function by echocardiogram/MUGA scan

Other:

Chronically infected patients must be stable enough to meet life expectancy requirement

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior interferon for cancer
Prior interferon alfa for viral infections (i.e., hepatitis) must be discussed with Study Coordinator

Chemotherapy:

At least 1 week since prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

At least 1 week since prior radiotherapy

Surgery:

Not specified

Other:

Prior antiretroviral therapy allowed
At least 1 week since prior acute treatment for any serious or life-threatening infection
No concurrent local treatment unless discussed with the Study Coordinator
No concurrent acute treatment for any serious or life-threatening infection
Concurrent antiretroviral therapy allowed

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT00002621

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 10 Locations for this study

See Locations Near You

Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Tomorrows Children's Institute
Hackensack New Jersey, 07601, United States
Mission Saint Joseph's Health System
Asheville North Carolina, 28801, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base Texas, 78236, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
McGill University Health Center - Montreal Children's Hospital
Montreal Quebec, H3H 1, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan , 00936, Puerto Rico
Clinique de Pediatrie
Geneva , 1211, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT00002621

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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