Interferon Alfa in Treating Children With HIV-Related Cancer

Children's Oncology Group

Status and phase

Completed

Phase 2

Conditions

Lymphoma

Leukemia

Unspecified Childhood Solid Tumor, Protocol Specific

Treatments

Biological: recombinant interferon alfa

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00002621

CDR0000063972 (Other Identifier)

9362

POG-9362 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment

8 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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