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A PHASE II STUDY OF ALPHA INTERFERON (ALPHA INTERFERON) IN HIV-RELATED MALIGNANCIES


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Leukemia, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

A PHASE II STUDY OF ALPHA INTERFERON (ALPHA INTERFERON) IN HIV-RELATED MALIGNANCIES


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

V. M. Whitehead, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Montreal Children's Hospital at McGill University Health Center

Authority:

United States: Federal Government

Study ID:

CDR0000063972

NCT ID:

NCT00002621

Start Date:

December 1994

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • recurrent childhood acute lymphoblastic leukemia
  • stage I childhood lymphoblastic lymphoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • unspecified childhood solid tumor, protocol specific
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • untreated childhood acute lymphoblastic leukemia
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • stage I childhood small noncleaved cell lymphoma
  • stage I childhood large cell lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage II childhood large cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Tomorrows Children's InstituteHackensack, New Jersey  07601
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Via Christi Regional Medical CenterWichita, Kansas  67214
Mission Saint Joseph's Health SystemAsheville, North Carolina  28801